Good day, ladies and gentlemen. Welcome to the Third Quarter 2017 Catabasis Pharmaceuticals' Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Andrea Matthews. You may begin..

Thank you, Michelle. Welcome to today's Catabasis Pharmaceuticals’ conference call where we will provide a corporate update and review our third quarter 2017 financial results. With me today are Jill Milne, Chief Executive Officer; Joanne Donovan, Chief Medical Officer; Ted Hibben, Chief Business Officer; and Andrew Nichols, Chief Scientific Officer.

We issued a press release after the market closed today summarizing our corporate update and our Q3 2017 financial results, which we will reference on today's call. This press release is available on our website.

I would like to note that during today's call, we will make statements related to our business based on current and future expectations that may be considered forward-looking statements under federal securities laws. Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties.

Including uncertainties related to the final trial design of our planned Phase 3 trial in DMD. Availability and timing of topline results from this trial, and our ability to obtain financing on acceptable terms in a timely manner to fund the certain development activities for the trial.

And other factors discussed in our most recent quarterly report on Form 10-Q, which we filed this afternoon with the SEC and is also available on our website. Such statements represent our judgment as of today and Catabasis undertakes no obligation to publicly update any forward-looking statements except as required by law.

With that, let me pass the call over to Jill Milne, Chief Executive Officer, who will provide a corporate update.

Joanne Donovan, our Chief Medical Officer, will review our clinical programs for edasalonexent and will be followed by Andy Nichols, our Chief Scientific Officer, who will provide an update on edasalonexent biomarker results and our cystic fibrosis program. Jill will then wrap things up with the financial update.

Jill?.

Thank you, Andrea. Good afternoon, everyone, and thank you for joining us today for an update on our third quarter 2017 financial results and recent business progress. I'll start with our lead program edasalonexent in Duchenne muscular dystrophy.

The hallmark of Duchenne is progressive muscle degeneration and weakness impacting boys from a very young age. For these patients, their families and treating physicians the number one goal of treatment is to slow the decline in physical function, enabling the boys to walk longer, be independent longer, and live longer.

We're focused on improving the lives of patients affected by rare diseases and we are excited about the positive results from our MoveDMD trial, in which edasalonexent substantially slowed the rate of functional decline in young boys with DMD regardless of mutation. We believe edasalonexent can become the foundational therapy in DMD.

Our Phase 3 trial, which we expect to initiate in the first half of 2018, will evaluate edasalonexent as monotherapy in four to seven year old boys affected by Duchenne. The trial is designed to bring edasalonexent to the market as efficiently and quickly as possible to benefit affected boys.

However edasalonexent’s potential extends beyond this initial registration trial. We believe that edasalonexent can transform disease trajectory in all boys regardless of mutation as monotherapy or in combination with dystrophin targeted therapies. From the time of diagnosis and continuing over a patient's lifetime.

We're also further exploring both our pre-clinical findings showing that edasalonexent had beneficial heart effects in animal models of DMD and our clinical observations showing a normalization of heart rate in edasalonexent treated boys.

Further, assessment of edasalonexent’s effects on cardiac health is particularly important as cardiac failure is often the ultimate manifestation of DMD. Joanne Donovan, our Chief Medical Officer will provide an update on our edasalonexent clinical program.

Andy Nichols, our Chief Scientific Officer will then share new edasalonexent biomarker results from the MoveDMD trial as well as recent data from our CAT-5571 program in cystic fibrosis.

Joanne?.

Thank you Jill. and good afternoon everyone. At the World Muscle Society Congress last month, we received a very positive response to our pre-specified data analysis from our MoveDMD trial of edasalonexent. I'm going to provide an overview of these results today and will also outline plans for our Phase 3 registration trial.

The most important goals of the MoveDMD trial were to see proof-of-concept and to guide the design of our Phase 3 trial and we achieved both. In addition, to continuing to show safety and tolerability, we determined appropriate and meaningful end-points, identified a dose with clinically meaningful effects and have been able to power a Phase 3 trial.

This was enabled by the design of the MoveDMD trial. We enrolled boys aged four to seven who were not on corticosteroids. We specifically designed the trial to regularly assess measurements of muscle functions as prespecified analyses. Knowing that, these are the only types of endpoints acceptable for approval by FDA.

They reflect every day muscle function, the number one priority for parents and physicians. The design allowed us to measure changes, in functional abilities during a period of about 39-weeks prior to the Phase 2 treatment period. And compare the rates of change during this control period to treatment period on edasalonexent.

We measured four assessments of muscle function appropriate for four to seven year old boys all of which have president and end-points in pivotal trials in Duchenne. These include three age appropriate time function tests, ten-meter walk run, four-stair climb, and time to stand.

We also performed the North Star Ambulatory Assessment, a composite measure designed specifically for DMD. For the time function tests and North Star Ambulatory Assessment, the boys were declining in the control period.

But after they started on a 100-mg/km of edasalonexent, the rate of decline was decreased and in fact they stabilized through 36-week treatment. We saw this consistently for all the measures.

We've talked with KOL’s about the MoveDMD trial results and the consistently positive results strongly support that edasalonexent treatment substantially slows disease progression. We saw a greater treatment effect, with 100 mg/kg dose compared with the 67 mg dose consistent with a dose response.

The results I'm going to discuss today and which we shared at World Muscle were for the 100 mg/kg treatment group. As this is the dose that we anticipate taking forward. We plan to submit additional data for presentation at scientific meetings next year.

The North Star Ambulatory Assessment is a validated composite measure of 17 physical function tests, which we are planning to use as the primary endpoint for our Phase 3 trial. The activities tested include a range of functions from the ability to stand or walk to the ability to run or to hop on one leg.

With each activity, assessed by a trained clinical evaluator. The maximum possible score with North Star is 34. And at the beginning of the control period the boys had an average score of 22, indicating that they're not able to perform well on all the 17 assessments.

During the control period averaging 39 weeks, the average decline in score was more than five points, indicating that the boys decreased or even entirely lost functional ability on multiple of the 17 assessments during the control period. The decline observed with typical for boys in this age range.

On edasalonexent, 100 mg/kg there was a clear stabilization of the North Star score through 36 weeks with no decline in overall score.

Looking at the individual patient results for North Star in more detail, we find that there are boys being treated with edasalonexent in our study that gain new abilities for example to run, to hop, to jump, which they did not achieve during the control period. This is beyond our expectations and we're very encouraged by these individual changes.

For the 10-meter walk/run, boys are asked to run or to walk a distance of 10 meters as fast as they can. Over the control period, an average of 39 weeks when not on edasalonexent, the boys lost 14% of their speed when performing the 10-meter walk/run. This is a typical decline in walk speed over that nine to 10 month period.

And unfortunately, this decline or an even greater rate of decline continues with these boys as they grow older. On edasalonexent, 100 milligrams per kilogram, the boys maintain the same average speed to perform the 10-meter walk/run and showed a clear stabilization after 36 weeks.

What's important is that we changing the trajectory of the disease by slowing the decline in function. For the 4-stair climb, at the end of the control period, the boys in the trial had declined by 24%. Once on edasalonexent again the speed to perform this assessment is maintained over 36 weeks and it stabilized.

For time to stand, at the end of the control period, the boys had declined by close to 40% in their speed. Over 36 weeks on 100 milligrams per kilogram of edasalonexent, the speed for the time to stand is maintained and again we see stabilization for boys on treatment.

Overall, what we find most compelling is the consistent preservation of function across all four of these well validated endpoints that are supported by regulators. Physicians have commented that the differences are clinically meaningful. And then it was very encouraging to see boys functional abilities stabilized over six to nine months.

From the MoveDMD Phase 2 trial results, we've been able to learn about edasalonexent’s functional effect which is enabled us to confidently prepare for a Phase 3 trial.

In addition to and supportive of these positive effects on muscle function, we saw changes across measures of muscle health that are consistent with positive edasalonexent treatment effects. Four muscle enzymes were measured in the MoveDMD trial, these muscle enzyme levels are known to increase with muscle damage.

Following treatment with edasalonexent, the levels of all four enzymes showed statistically significant decreases compared to baseline, indicative of a decrease in muscle injury and improvement in muscle integrity. We also assess the MRI T2 composite measure of five lower leg muscles as an exploratory biomarker.

That was the primary endpoint for the Phase 2 12 placebo-controlled trial. As we announced in January, we saw decreased with edasalonexent. Although, it did not reach statistical significance versus placebo at 12 weeks when measured at the last available MRI reading at either 24 or 36 weeks.

The increase in MRI T2 was significantly slowed compared to the rate of change in the control period of the same boys prior to commencing dosing.

This reduction of muscle inflammation as evidenced by MRI T2 is aligned with a very consistent stabilization of disease progression shown in the four pre-specified assessments of muscle function that I just discussed. The MoveDMD Phase 2 biomarker data additionally supports a treatment effect and Andy will discuss these shortly.

With an eye on our pivotal trial and the importance placed by regulators on a medicines total risk benefit profile. The safety profile is key, edasalonexent has continued to be well tolerated with no safety signals observed to-date in the MoveDMD trial now with over 25 patient years of pediatric exposure.

Most adverse events have been mild in nature with no edasalonexent-related serious adverse events. Boys treated with edasalonexent continue to increase their height and weight along the growth curves for unaffected boys through 36 weeks. This is clearly differentiated from the common side effects of steroids that are the current standard-of-care.

And this is important because we want to see these boys grow and develop like their peers without delays in puberty, excess weight gain, and diminished stature. Jill mentioned observations that edasalonexent may have benefits on the heart.

Resting tachycardia is typically seen in Duchenne and it elevated heart rate was observed in boys when they started in the MoveDMD trial and was shown to decrease towards age normative values with edasalonexent treatment.

We find this intriguing due to published literature the tachycardia is the first cardiac observation that is followed by cardiac fibrosis and subsequently cardiomyopathy in boys with Duchenne. We've also seen positive heart effects with a reduction in cardiac fibrosis in preclinical models treated with edasalonexent.

We plan to further evaluate cardiac measures in future studies. Based on the consistency of the MoveDMD trial, as well as supportive regulatory input from FDA.

We planned a path to registration for edasalonexent, after the end of our – our end of Phase 2 meeting, we have confidence preparing to go forward to Phase 3, we're preparing to initiate a single global Phase 3 trial in boys with Duchenne in the first half of 2018 and expect top line results in 2020.

The Phase 2 trial, the Phase 3 trial plan has many fundamental elements in common with our Phase 2 MoveDMD trial including the patient population and key endpoints. The patient population planned for the Phase 3 trial will include boys aged four to seven regardless of mutation tied who have not been on steroids for at least six months.

We expect to enroll approximately 125 boys with two boys receiving edasalonexent for every one boy receiving placebo. We plan to have the primary endpoint be the North Star ambulatory assessment following 12 months of edasalonexent treatment compared to placebo.

North Star is as an endpoint for other drug candidates in Phase 3 trials in Duchenne that are currently in progress. And both FDA and EMA have expressed in the guidance documents that North Star is an important measurement in Duchenne.

After 12 months in the trial, we're planning an open-label extension to allow all boys enrolled the opportunity to receive edasalonexent. We extend our deepest appreciation to the boys and their family who participated and continue to participate in the MoveDMD trial.

Thank you all to the trial site staff, patient groups and members of the Duchenne community for all their support, enthusiasm and dedication towards improving the lives of people affected by Duchenne I’ll now pass the call over to Andy Nichols, our CSO, who will share the edasalonexent biomarker results, as well as an update on our cystic fibrosis program.

Andy?.

Thank you, Joanne, and good afternoon, everyone. Edasalonexent was designed to inhibit NF-κB, a protein that plays an important role in muscle health. Interestingly, NF-κB functions both downstream of dystrophin with regard to muscle function as well as upstream of dystrophin to regulate dystrophin expression.

In DMD, due to the lack of dystrophin, NF-κB has chronically activated and drives muscle inflammation, fibrosis and degeneration, while at the same time suppressing muscle regeneration.

We designed edasalonexent to inhibit activated NF-κB and that’s by to slow muscle degeneration, limit muscle inflammation and fibrosis, and enhance muscle regeneration, all of which we have demonstrated preclinically.

Importantly, we've also demonstrated the edasalonexent increased dystrophin protein production in combination with an exon skipping agent in preclinical models. Clinically, we've evaluated NF-κB activity in each phase.

We continue to see evidence supporting the biological activity and NF-κB inhibition with edasalonexent treatment at every stage of clinical development. In our Phase 1 trial in unaffected adult subjects, we saw a 70% inhibition of NF-κB following a single dose of edasalonexent.

In Phase 1 part of the MoveDMD trial in boys affected by Duchenne, we have evaluated gene expression signals of NF-κB inhibition following seven days of treatment. NF-κB is a transcription factor and therefore gene expression is the most proximal measure of edasalonexent activity and provides a sensitive measure following short-term dosing.

As we have shared previously, we saw significant and dose dependent decreases and expression of genes controlled by NF-κB at both the 67 mg/kg/day and 100 mg/kg/day doses given for seven days in Phase 1 in boys affected by Duchenne and selective base doses to move forward to Phase 2.

In Phase 2 we wanted to evaluate the activity downstream of NF-κB globally and look for indicators of the expected result and decrease in inflammation. The proteomic data that we've been collecting takes longer to generate and we've just received the first batch results.

We're happy to report that C-reactive protein or CRP was significantly decreased through the 100 mg/kg of edasalonexent treatment followed 12 and 24 weeks of treatment compared to baseline. The 36-week data not yet available.

CRP is a well characterized blood test marker that provides a global assessment of inflammation and is elevated in boys affected by DMD. The significant decrease observed in CRP supports biological activity of NF-κB inhibition by edasalonexent treatment decreasing inflammation.

We will be presenting the CRP data at the Action Duchenne Conference tomorrow. We are pleased to see the evidence supporting the biological activity and NF-κB inhibition with edasalonexent treatment in every stage of clinical development.

Turning to our cystic fibrosis program, as Jill mentioned, we presented new preclinical data for CAT-5571 last week at the North American Cystic Fibrosis Conference.

CAT-5571 shows significantly improved cellular clearance of the opportunistic and often fatal pathogen Burkholderia cenocepacia highlighting the potential for reducing the lung infection, which is a critical driver of disease progression in CF.

CAT-5571 is designed to restore host defense by activating autophagy, a mechanism for recycling cellular components and digesting pathogens. By restoring autophagy which is depressed in CF, host defense is reestablished to enhance the clearance of pathogens.

CAT-5571 has the potential to augment the efficacy of antibiotics and could also be used with other CF therapies including CFTR targeted agents. We’re continuing IND enabling activities in CAT-5571 and may expect to initiate a Phase 1 trial in the second half of 2018 and top line results in 2019.

I’ll now turn the call back over to Jill for a review of our third quarter financials..

Thank you, Joanne and Andy. Turning to our financials, our third quarter 2017 press release and 10-Q provided the details, so I’ll provide a brief summary. As of September 30, 2017, we had $21.7 million of cash and cash equivalents, which we expect to be able to fund operations through August 2018.

To advance edasalonexent in the Phase 3 trial, Catabasis expects to obtain additional funds through equity or debt financings or through collaboration or licensing transactions.

We also recognized collaboration revenue in the third quarter of $0.3 million from an option agreement with an undisclosed unaffiliated partner related to an earlier stage preclinical program. In the third quarter of 2017 our net cash used in operating activities was $7.4 million.

Our R&D expense was $4.8 million in Q3 2017 compared $5.9 million in Q3 2016, a decrease of $1.1 million. The decrease in research and development expenses was primarily attributable to the completion of certain clinical activities. Our G&A expense was $2.4 million in the third quarter of 2017.

Our operating loss was $7 million in Q3 2017, a decrease of $1.3 million versus Q3 2016. Our net loss was $7 million or $0.31 per share in Q3, a decrease by $1.4 million compared to our net loss in Q3 2016. For the third quarter we had weighted average common shares outstanding of 22.6 million.

Additional financial information is available in our 10-Q which we filed with the SEC earlier today. We are incredibly excited about edasalonexent's potential as a novel foundational therapy for Duchenne Muscular Dystrophy. And the consistency of the MoveDMD data gave me great confidence as we prepared to go into our Phase 3 trial.

We have seen substantial slowing in DMD disease progression and our Phase 2 trial has allowed us to rigorously design empower our Phase 3 trial.

We're also encouraged by the growing body of information that supports broad usage of edasalonexent for boys and men of all ages regardless of mutation type, and have plans in place to further our understanding of the full potential of edasalonexent.

While our primary focus is edasalonexent program, we continue to build our pipeline to drive long-term sustainable growth for the company. We're making great progress in our cystic fibrosis program.

We demonstrated clearance of an additional bacterial type with CAT-5571 and are encouraged by the results of our preclinical studies supporting its potential as an oral treatment for cystic fibrosis. We owe a tremendous debt of gratitude to the patients and their families supporting the study of edasalonexent.

I’ve had the opportunity to connect with many in the Duchenne community over the past few months and continue to be inspired by their perseverance and their hope.

Progressing into a pivotal study is a significant milestone for Catabasis, but more importantly it signifies that we are one step closer to potentially bringing a life changing therapy to the brave young boys affected by Duchenne. With that, I'll ask the operator to open up the call for your questions.

Michelle, can you please repeat the instructions and pull for questions? Thank you..

Sure. [Operator Instructions] Our first question comes from Hartaj Singh of Oppenheimer. Your line is open..

Great, thank you. Just a couple of quick questions. And again, really congratulations on all the progress.

Just on the perspective of Phase 3 design, if you can just talk a little bit about how long do you think the enrollment period will take? I mean, when? And then after that what's evaluation period? I know you'd mentioned when the readout would be, but if you can just kind of break that down a little bit as to how long you think the actual enrollment should take or it's designed to take and then the evaluation period which I guess then gets us into 2020? And then I just got a quick question on 5571.

Thank you..

Great. Thanks, Hartaj, this is Jill, I’ll take the first part of that question from you.

So far what we have been talking about with regard to enrollment and the top line results from the Phase 3 is that we expect to initiate the Phase 3 in the first half of 2018 and obviously much of our effort right now is making sure that we set that trial up in a way that allows enrollment to occur very efficiently.

We were quite pleased with enrollment and the rate of enrollment in our MoveDMD trial. So we're very encouraged by that as we enter into this next phase of clinical development. And with that if all goes as planned we will be prepared to release top line results in 2020.

And certainly as our plans are further refined, we will certainly give more details on the specifics around that..

Yes. Jill, I was just talking because I know that MoveDMD recruited fairly quickly for that 12-week endpoint.

I mean, is there a possibility, for example, if you've got a six-month enrollment period there could be three months? I mean, you just try to get a sense for if there's any possibility to maybe have a trial read out faster than 2020 or you know that's just how it's going to run?.

Yes. Certainly we've done our estimates in a conservative fashion, certainly MoveDMD enrolled quite rapidly. And our goal would be to move as efficiently and as quickly as possible. And I can assure you as soon as we are confident and shortening timelines we would absolutely do that.

But at this point it's best for us to say top line results in 2020, but it's something that's certainly top of mind for us..

Got it, got it. No worries. Thank you. And then just on 5571, I know you just mentioned towards the end of the prepared remarks that there's one other, I guess, organism that you're clearing out.

What's the biggest weight limiting step or the series of weight limiting steps, Jill, between 5571 getting into the clinic by the second half of next year? I mean, I know that there's been some preclinical data already presented.

So I guess, what's the – what are the series of steps that you need to get done before you’re in the clinic next year?.

Yes. So we’re currently in our IND enabling studies, so it's the completion of those studies and submitting our IND, and that's what's between us – between today and the time we initiate that Phase 1.

And as you can imagine, as we look at 2018 we have a pivotal Phase 3 trial in – with edasalonexent starting in the first half, so our intention is to initiate that Phase 1 with CAT-5571 as quickly as we can after that..

Great. Thank you very much..

Our next question comes from Ted Tenthoff with Piper Jaffray. Your line is open..

Great. Thank you very much. And I appreciate the update and congratulations on the data, I think it’s really compelling. So obviously your focus is on getting to Phase 3 after running primary important makes sense.

How important do you think some of these secondary endpoints are going to be just in terms of generating the overall submission to the FDA and are we seeing sort of any changes in terms of what the FDA and/or key opinion leaders are looking for, in terms of approvable end-point..

Yeah, thanks for the question Ted, I am going to let Joanne address that..

Yes, I think that we have – thanks Ted. We are looking at the three time function tests that are age appropriate. Of course that is a shift from what you've seen in other studies with the six minute walk.

But, the agencies are very open to these endpoints and in fact have in the guidance’s both from FDA as well as EMA have spoken to those as appropriate for this age group. They do want to see the primary endpoint of course, but they also want to see all of these end-points also supportive.

So it gives a more complete picture of the effects of edasalonexent in these boys who are going to be exploring these as we move forward into Phase 3..

That's hopeful and I guess maybe kind of thinking a little bit longer term and this might be a bit unfair but how do you ultimately envision moving to younger boys and/or older boys either with edasalonexent alone or in combination.

I mean there would obviously be additional stories but how do you sort of think that prioritizes, if the Phase 3 trial reports positively..

Yeah, that's a great question. Maybe I'll start and then I’ll let Joanne supplement. So we certainly, our pivotal trial will be in the boys ages four to seven. And that we believe will support registration of edasalonexent in DMD. We intend to initiate a non-ambulatory study in the older boys as soon as we can.

Now, while we think we can register edasalonexent based on that single pivotal Phase 3, study we do think it's important to show efficacy in the older boys as well.

And we believe based on what we've seen with this mechanism, pre-clinically and then some of our initial intriguing clinical data from the MoveDMD trial that we believe, we could have a great benefit in the older non-ambulatory boys and especially on the heart. And that's something we are very eager to test in the clinic.

With regards to be younger boys absolutely, we see edasalonexent as potentially a foundational therapy in DMD, where we envision boys would be put on a edasalonexent at time of diagnosis. And that means we need to go younger than four years old, we intend to do that in our future plans.

What that would involve is likely a new formulation of edasalonexent. Because as you know right now our product presentation is in gel cap, which is a size that four year olds can take, but we would need to go smaller for the younger boys and that’s something that in our plans as well. And if I’d left anything out, I would let Joanne chime in..

That’s a very important question, Ted. Because we really see this as foundational therapy across all age groups cross mutation types. And you also mentioned combination therapy and we have boys in the study that are eligible for edasalonexent and they’re moving a long and will have additional.

There are at 51 skip-able and we will be in – we have continuing to follow them from a safety point of view. Because we really think that this is an additional important treatment paradigm to be treating in combination..

All right, excellent. Thank you..

Thanks, Ted..

Our next question comes from Joel Beatty from Citi. Your line is open..

Hi thanks for taking the questions.

The first question is on the Phase 3 trial design, could you share a little more detail on the powering assumptions and how many patients would be needed to enroll in the trial and then maybe also what the total cost of the trial would be?.

Sure I’ll let Joanne start?.

Sure, Joel. As you know we don’t – we look at powering, not just a single measurement, but look at it in a number of ways. So we think that with 125 boys we have robustly power that and importantly added 2:1 ratio. So we have more safety exposure and more opportunity for boys to be exposed to edasalonexent during the first part of this study.

So we do think that it's well powered for that endpoint given the data that we have from the MoveDMD trial that was one of the great values of that study to be able to compare the long-term, control period of nine months with the treatment period of around nine months and be able to go into our Phase 3 study with confidence based on those comparisons..

And with regard to cost of the Phase 3 right now, we're estimating the direct cost for the Phase 3 pivotal – to be in the range of $20 million to $25 million and certainly as our plans are finalized will be refining those numbers..

Okay, great. And then maybe one other question just related to the Phase 3 again, what are the gating steps you need to take place between now and the end of the first half of next year or two, ensure the trial gets underway in that timeline. Thanks..

Joanne?.

So one question, I’m sure – is there any additional regulatory clearance and we had our end of Phase 2 meeting, we are moving ahead, we don’t have any other meetings with FDA to plan for that.

And we are doing the usual preparation work talking to investigators and we're really getting a great response, there is a lot of enthusiasm out there in the community for a drug with this safety and efficacy profile..

Great, thank you..

Thanks Joel..

Our next question comes from Jeff Chen of Cowen. Your line is open..

Hi, good afternoon. Thank you for taking my questions. Maybe the first one is on the data analysis that you have so far for the Phase 2.

Have you looked at sort of intrapatient correlations meaning that within the individual patient, if patients witnessed sort of a stabilization on one endpoint or one measurement does this patient also show – typically show stabilization on other endpoints and vice versa?.

Thanks, Jeff.

Joanne?.

Yes, we will be looking at that in some detail and I can say certainly that that's generally true that the ones that do better in one measure do better in, due better in others we've provided a little bit of that data for the Phase 3 part of the study where we also saw that and we'll certainly be presenting more next year..

That’s very interesting. Thanks. That's very helpful. And then on the Phase 3 design wise, how often were you or if that all we'd be taking sort of measurements in terms of patient endpoints in the first primary or secondary endpoints or is that – we're trying to just way until the end of the study and then take one measurement..

Yes, so we would be comparing the – we're looking at it after 12 months. We think is the primary - intention of the primary endpoint be at six months. We will of course be measuring in the intervals between – and continuing to follow these boys from a safety point of view..

Yes and just to clarify the primary endpoint would be after twelve months, yes..

Do you envision sort of building in the interim look on futility or even may be overwhelming efficacy type of looks..

We’ll have the DSMB following the study closely..

Got it. Thank you..

Thanks Jeff..

There are not further questions, like turn the call back over to Dr. Jill Milne, Chief Executive Officer for any closing remarks..

Thank you, Michele. We've made a men’s progress with edasalonexent, we are excited and motivated by the strong and consistent Phase 2 open-label data, we're looking forward to initiate in the Phase 3 trial as move edasalonexent towards registration. We believe the edasalonexent is a unique and important opportunity to treat Duchenne.

Our efforts continue to be focused on making a difference for people with Duchenne muscular dystrophy and their families. Thank you all for joining our call today and for your continued support. We look forward to speaking with you again soon and keeping you updated on our progress throughout the remainder of the year.

Have a good evening, Andrew that concludes today a webcast replay will be available for 90 days via the Investor Relations page on our website at www.catabasis.com. Thank you..

Ladies and gentlemen, thank you for spending in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day..