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Edited Transcript of CATB earnings conference call or presentation 14-Mar-19 12:30pm GMT

Q4 2018 Catabasis Pharmaceuticals Inc Earnings Call

CAMBRIDGE Mar 14, 2019 (Thomson StreetEvents) -- Edited Transcript of Catabasis Pharmaceuticals Inc earnings conference call or presentation Thursday, March 14, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Andrea L. Matthews

Catabasis Pharmaceuticals, Inc. - VP of Corporate Affairs

* Andrew J. Nichols

Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer

* Noah Clauser

Catabasis Pharmaceuticals, Inc. - VP of Finance

* Jill C. Milne

Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director

* Joanne M. Donovan

Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development

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Conference Call Participants

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* Hartaj Singh

Oppenheimer & Co. Inc., Research Division - Research Analyst

* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP & Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the Q4 2018 Catabasis Pharmaceuticals Earnings Conference Call. (Operator Instructions) It is now my pleasure to turn the conference over to your host, Andrea Matthews, Vice President of Corporate Affairs. Please go ahead, Miss.

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Andrea L. Matthews, Catabasis Pharmaceuticals, Inc. - VP of Corporate Affairs [2]

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Thank you, Hailey. Welcome to today's Catabasis Pharmaceuticals conference call, where we'll provide a corporate update and review our fourth quarter and full year 2018 financial results. With me today are: Jill Milne, Chief Executive Officer; Joanne Donovan, Chief Medical Officer; Andrew Nichols, Chief Scientific Officer; and Noah Clauser, Vice President of Finance.

We issued a press release this morning, summarizing our corporate update and our Q4 and full year 2018 financial results, which we will reference on today's call and is available on our website. We are also using slides during today's call that are available within the Events & Presentations section in the Investors part of our website.

I would like to note that during today's call, as mentioned on Slide 2, 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 those discussed in our most recent annual report on Form 10-K, which we filed this morning 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, who will provide our corporate update. Joanne will provide an update on our Phase III PolarisDMD trial for edasalonexent and clinical activities and will be followed by a research and development update from Andy. Noah will then provide the financial update, and Jill will wrap things up. Jill?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [3]

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Thank you, Andrea. Good morning, everyone, and thank you for joining us today for our Fourth Quarter and Full Year 2018 Financial Results and an update on progress. In 2018, we focused on laying the foundation for a successful Phase III trial for edasalonexent in Duchenne. We secured funding, completed the study design and initiated the Phase III PolarisDMD trial that is intended to support an application for the commercial registration of edasalonexent. With this foundation in place, we are off to a strong start in 2019 as outlined on Slide 3.

We initiated our PolarisDMD trial in September of last year, and we are making excellent progress opening clinical trial sites for enrollment, enabling us to respond to inbound interest from many enthusiastic families. The next couple of months are important as the remaining clinical trial sites open for enrollment and patients continue to be screened and dosed. We are pleased that our rate of site activation and enrollment has been facilitated by the approvals we received to run our Phase III trial internationally.

We are particularly pleased with the approvals that we have received from European countries, which reflect their support of our Phase III design. As we have done in the past, we'll provide high-level qualitative updates on our PolarisDMD trial and plan to announce when we have completed enrollment, which we expect to occur in the second quarter this year. And we expect to report top line Phase III results in the second quarter of 2020.

In preparation for our next phase of development, Catabasis has strengthened its financial position and Board of Directors to support our planned future transition to a commercial-stage organization. We added to our balance sheet in Q1, and are using these funds to support certain NDA enabling activities, initial commercial preparations and to extend our runway well beyond our expected Phase III results in 2020. Noah will provide the financial details on today's call.

Additionally, in the first quarter of this year, we appointed Gregg Lapointe, who has extensive financial and commercial experience in rare disease as well as a Joanne Beck, who has deep pharmaceutical development and operational expertise to our Board of Directors. Together, both the Gregg and Joanne are valuable additions to our board as we continue NDA enabling activities and begin initial preparations for the potential commercial launch edasalonexent following the completion of our current Phase III trial in Duchenne.

We have developed a roadmap to commercialization and have begun work on these activities. As we have mentioned, we plan to commercialize edasalonexent in North America ourselves, and outside of North America either ourselves or with a partner. We believe that we are well positioned to build on the positive momentum that we have created going forward.

With Phase III underway, we are adding to the existing evidence supporting the potential of edasalonexent. We believe that edasalonexent can fill an important role as a new foundational therapy for all affected by Duchenne, regardless of their mutation type and throughout their lifetime.

Joanne and Andy will speak more to the broad potential areas for benefit, including on skeletal and cardiac muscle as well as a bone health. Importantly, as outlined on Slide 4, we believe that these benefits can be achieved both as monotherapy and in combination with other therapies. Andy will also briefly touch on NDA enabling activities in commercial preparations from a CMC perspective. Next, Joanne will provide a clinical update, including more information about our PolarisDMD trial and recent MoveDMD results that continue to build our confidence in the potential of edasalonexent to change the treatment paradigm for Duchenne. Joanne?

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Joanne M. Donovan, Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development [4]

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Thank you, Jill, and good morning, everyone. Before sharing an update on our progress on our Phase III PolarisDMD trial, I want to quickly remind you of the trial design.

As seen on Slide 5, this is a randomized double-blind, placebo-controlled trial. We are planning to enroll about 125 boys. As we did in our Phase II MoveDMD trial, PolarisDMD is enrolling boys ages 4 to 7, up to their eighth birthday. The PolarisDMD study includes boys regardless of mutation type, who have not taken steroids for the past 6 months.

The randomization is 2 to 1, such that for every 2 boys that receive 100 milligrams per kilogram of edasa, 1 boy will receive placebo. The primary efficacy endpoint is change in the North Star Ambulatory Assessment score after 12 months of treatment with edasalonexent compared to placebo.

North Star was chosen as the primary endpoint because it's age appropriate for the boys in this trial as well as supported by FDA. Key secondary endpoints include the timed function tests time to stand, 4-stair climb and 10-meter walk run. Boys treated with edasalonexent showed slowed disease progression compared to the off-treatment control period across all of these same functional measures in our phase II MoveDMD trial and open-label extension.

By inhibiting NFkB, edasalonexent has the potential to provide benefits to those affected by Duchenne. As part of this trial, we're assessing muscle function and we're also performing cardiac monitoring as well as growth in bone measurements. We see these areas as important potential differentiators for edasalonexent from the current standard of care.

Our focus initially has been opening clinical trial sites for enrollment in the United States, as we anticipate enrolling the majority of patients in the U.S. We now have more than 2/3 of the sites in the U.S. open for enrollment as shown on Slide 6. Extending beyond the U.S., we're enrolling patients globally and have also clinical trial sites open for enrollment in Canada and Australia. We're working diligently and we expect additional sites in the U.S., Canada, Australia, Europe and Israel to open for enrollment in the coming weeks. The interest in the trial is strong, we have a long list of patients who have expressed interest in our trial, and we're connecting them with clinical sites in the U.S. and globally. We are receiving great interest and positive feedback from families and physicians, reflecting the high level of unmet need in Duchenne and enthusiasm for edasalonexent.

We appreciate all of the support and partnership that we have with patient advocacy organizations around the world on this global trial. These close relationships provide us with opportunities to partner on recruitment and patient advocacy organizations are also helping to field questions from families about PolarisDMD and edasalonexent.

The regulatory approvals of our clinical trial applications for our PolarisDMD trials have gone well. We are pleased that we have received approvals to run our Phase III PolarisDMD trial at all European countries where we applied, the U.K., Ireland, Sweden and Germany. For many regulators, this was the first opportunity to review edasa in detail, and these approvals reflect support of the Phase III design. As Jill shared, we continue to deepen our understanding of edasa as we evaluate data from our ongoing MoveDMD open-label extension. I presented edasa clinical results last month at the 17th International Conference on Duchenne and Becker muscular dystrophy in Rome.

On Slide 7, in the Phase II MoveDMD trial and open-label extension, we saw that boys with Duchenne treated with edasa on average grew in line for both height and weight with the growth of unaffected boys in the same age range.

Boys treated with edasa grew an average of 2.1 inches taller per year, gained 2.9 pounds per year and their overall BMI decreased from the 70th percentile of unaffected boys to the 55th percentile over 72 weeks of treatment, approaching the average BMI for unaffected boys. This contrasts with boys treated with corticosteroids, the standard of care in Duchenne, who typically experienced excess weight gain, curtailed growth and substantially increased BMI.

Additionally, I presented the efficacy results through 72 weeks of edasa treatment that showed preservation of muscle function and sustained disease modifying effects in all assessments of muscle functions compared to the off-treatment control period. Significant decreases in muscle enzymes, including CK, through 72 weeks were also seen, supporting the durability of edasa treatment effects as well as significant decreases in heart rate towards age normative value, supporting the potential cardiac benefits of edasa. We saw a significant improvement in the lower leg MRI T2 compared to the off-treatment control period as well as slowing in the rate of fat accumulation, which is all consistent with the muscle function and biomarker results.

In addition to these positive efficacy and safety results that we've seen with edasa as a monotherapy, we've provided a foundation for a combination therapy in the clinic as outlined on Slide 8. The combination of edasa and the approved exon skipping therapy, EXONDYS 51, developed by Sarepta Therapeutics, was well tolerated with no safety signal. 2 boys in the MoveDMD trial open-label extension received both for an average of a year. Edasa has been previously shown to increase dystrophin expression in combination with exon skipping therapy in mdx mice. And this preclinical proof of concept is supported by research showing that NF-kB can inhibit dystrophin expression. Thus, by inhibiting NF-kB, edasa has the potential to enhance dystrophin-targeted therapies, such as EXONDYS 51. Demonstrating safe co-administration opens up many other possible combinations with additional emerging exon skipping therapy.

This month, we are launching a new open-label extension trial called the GalaxyDMD trial, shown on Slide 9. All boys currently participating in the MoveDMD trial open-label extension are transitioning to GalaxyDMD. Due to request from families that participated in MoveDMD, we are also enrolling siblings that are now in the age range to participate as well. These families have extensive experience with edasalonexent, and we appreciate their dedication to MoveDMD and of course also their enthusiasm for edasa.

When boys in Phase III PolarisDMD trial complete the 12-month placebo-controlled portion, they will also have the opportunity to participate in GalaxyDMD. In that trial, we are also monitoring assessments of muscle function as well as long-term safety in bone health. Due to the excellent safety profile of edasa, GalaxyDMD has a streamlined visits schedule with visits every 6 months. Our primary focus with GalaxyDMD is to look at long-term safety and to collect data in boys as they get older to support registration filings. At this point, the boys from the MoveDMD trial have received edasa for more than 2 years and their average age is close to 9.

I'll now pass the call over to Andy Nichols, our CSO, for our research and development update. Andy?

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Andrew J. Nichols, Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer [5]

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Thank you, Joanne, and good morning, everyone. As we look to the future to support potential commercial adoption of edasalonexent, we recognize that the mechanism of action and benefits of edasa need to be clearly articulated and well understood. We designed edasalonexent to inhibit NF-kB because of its important role in bone and heart health, in addition to its well-known critical role in skeletal muscle disease.

We believe that the chronic activation of NF-kB in Duchenne has negative affects not only on skeletal muscles but also on bone and heart health, and that NF-kB inhibition by edasalonexent could be beneficial to reduce skeletal muscle disease, positively impact cardiomyopathy and reduce risk of fractures, while also allowing normal growth and development.

Boys and men with Duchenne have weakened bones and reduced bone growth. And unfortunately, adding steroid treatment creates the perfect storm with increased damaging effects seen, including increased fractures and further curtailed growth.

To provide additional data on the benefits of edasalonexent, we're performing a series of preclinical experiments to compare and contrast edasalonexent with current and emerging therapies in addition to combinations with the therapies. We're looking to further demonstrate the broad potential therapeutic benefits of edasalonexent in our ongoing preclinical studies, and plan to submit the results of these studies or presentation at future scientific conferences.

Our goal is to submit an NDA for edasalonexent for the treatment of Duchenne in early 2021. As Jill mentioned, we are engaged with NDA enabling activities as well as initial activities to support potential commercial launch. Correspondingly, we have completed our long-term toxicology studies and to date the results support the excellent safety profile seen in the clinic. For CMC, we believe the path to NDA is laid out and we have determined our supply chain strategy to launch.

Edasalonexent is a small molecule with a straightforward synthesis. As such, it does not have many of the production and analytical complexities faced by other Duchenne treatments in development. We are confident in the ability of our supply chain and batch strategy to support a commercial launch.

In terms of regulatory status, we have had regular phase-appropriate interactions with FDA on edasalonexent. We understand that CMC is a critical component for a Phase III program to support both development and ensure a successful commercial launch. And we are focused on ensuring that everything continues to progress smoothly. Noah will share our financial update. Noah?

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Noah Clauser, Catabasis Pharmaceuticals, Inc. - VP of Finance [6]

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Thanks, Andy, and good morning, everyone. Turning to our financials, our fourth quarter 2018 press release and 10-K provide the details, so I will provide a brief summary. As of December 31, 2018, we had $37.6 million of cash, cash equivalents and short-term investments. Following December 31, 2018, we raised an additional $20.5 in net proceeds from equity financings. Based on our current operating plan, we believe we have sufficient capital to fund operations into the fourth quarter of 2020.

Our net cash used in operating activities was $5.3 million for the fourth quarter of 2018 and $23.5 million for the full year of 2018. As we mentioned on our last earnings call, in 2018, we completed all our payment obligations under our previous credit facility, and we currently have no long-term debt obligations.

Our R&D expense was $3.7 million in Q4 2018 and $17 million for the full year 2018 compared to $4 million in Q4 2017 and $18.7 million for the full year 2017. The decrease in research and development expenses was primarily attributable to a decrease in the cost associated with programs not related to edasalonexent. Our G&A expense was $2.4 million in the fourth quarter of 2018 and $9.3 million for the full year 2018 compared to $1.7 million in the fourth quarter of 2017 and $8.9 million for the full year 2017. Our operating loss was $6.1 million in Q4 2018, a decrease of $0.6 million versus Q4 2017. Our net loss was $6.1 million or $0.85 per share in Q4, an increase of $0.6 million compared to our net loss in Q4 2017. Net loss for the full year 2018 was $25.9 million or $5.12 per share compared to $27.4 million for the full year 2017. For the fourth quarter, we had weighted average common shares outstanding of $7.1 million.

Please note, that per share figures reflect the 1 for 10 reverse stock split of our common stock that was effective on December 28, 2018.

Looking forward, we expect our quarterly net loss to be fairly consistent over the course of 2019, but higher than it was in the last 2 quarters of 2018 due to a ramp up of PolarisDMD trial costs. Additional financial information is available in our 10-K, which we filed with the SEC earlier today. I will now pass the call back over to Jill.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [7]

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Thank you, Noah. As the team discussed this morning, Catabasis is in an excellent position. We are progressing well with our Phase III trial for edasalonexent and Duchenne and have strengthened our financial resources and Board of Directors as we prepare for the future.

On Slide 10, we have outlined the potential advantages of edasalonexent and why we believe it represents a significant commercial opportunity. There is a compelling need and desire for a therapy with the characteristics of edasalonexent as we hear frequently from physicians, patients and their families. This community is eager for a therapy without the devastating side effects of current standard of care that can slow disease progression and potentially give their sons more time to move, play and grow.

We are also inspired to provide the Duchenne community with the treatment that could have a meaningful impact on its own and in combination with other therapies. We've shown consistent positive clinical results with edasalonexent in 4- to 7-year-old patients with Duchenne for close to 2 years of treatment. The consistency of the data and the excellent safety profile observed to date, show promise to differentiate edasalonexent from other DMD therapies that are available or in development.

Beyond DMD, we see additional opportunities for edasalonexent down the road with expansion into other indications, including Becker muscular dystrophy. With that, I'll ask Hailey to open up the call for your questions. Hailey, can you please repeat the instructions and poll for questions. Thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Hartaj Singh of Oppenheimer.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [2]

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And just had a couple of quick questions. So really interesting update, Jill, Joanne, on the growth parameters of the boys as they are getting older. One of the things that sometimes investors have asked us is that, is edasalonexent sort of a steroid sparing regimen, the early data indicating sort of increase in functional benefits, biomarkers getting ready. But now what you're seeing is benefits in 1 to 2 years that are very differentiated from steroids. So I guess my one question is, how would you think when you're thinking ahead a year, 2 years from now to potentially launch edasalonexent of -- from a pricing perspective? I'm not looking for specific price, but just what is the value for product like this? Is it sort of more rare disease sort of product now really because it's so differentiated from steroids and currently approved regimens on the market? And I just had a couple of follow-ups.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [3]

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Yes, thank you for the question, Hartaj, this is Jill. Yes, and so as you point out it's early for us to begin to talk about pricing of edasalonexent, but we do feel we've shown great potential of edasalonexent in boys affected by Duchenne and think there is a significant commercial opportunity there. This is certainly a rare disease. But I think edasa has the advantage of potentially being applicable across the patient population, across all ages and having potential benefits across multiple different aspects of the disease with a very, so far, clean safety profile.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [4]

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Great, Jill. So I mean, just in the frame of reference, I know that steroids are priced sort of in the tens of thousands. I believe, EXONDYS 51 is close to $400,000. I mean, so would you -- could you give us a frame of reference as to where you think a therapy like this would be more appropriate? Again, not really looking for any pricing, but just from a pharmacoeconomic kind of modeling perspective how to think about it?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [5]

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Yes, that's a great question. And we certainly internally are doing a lot of work to understand that and to really understand the full value of edasalonexent and where it fits in the treatment of paradigm. I think you've definitely outlined sort of the boundaries that where drugs are priced for patients affected by Duchenne and that's something that we're paying a lot of attention to. I think one thing to point out from a health economics point of view with steroids, of course, the steroids are priced in the tens of thousands of dollars, and there are associated -- other costs associated with treating patients with steroids that have to be addressed. We all know that steroids have shown benefits in these boys in delaying time to loss of ambulation and extending lifespan. But associated with that are some of the metabolic effects and other effects that has to be addressed with other therapies, so there is a big health economics analysis that has to be completed to really understand that. So you'll certainly be hearing more to come from us as time progresses and as we advance edasalonexent.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [6]

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Great, no, that's great, Jill. And then just secondly on just your FDA interactions. I know that previously investors have been interested in a potential meeting with the FDA to discuss sort of an earlier approval or accelerated approval. Just any thoughts? I mean, not really looking for your actual meetings with the FDA, but more so just how to think about, sort of, what are the questions that the agency is asking? What are they interested in? And then just one last question after that.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [7]

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Great. Yes, and so -- yes, as you point out, Hartaj, as you know, we don't share details of our interactions with the regulators. But with that said, we're all aware that the FDA has expressed an interest in MRI and neuromuscular disease, and that's clearly expressed in their guidance in Duchenne. It's our understanding that the FDA continues to seek additional information about MRI.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [8]

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Great, fantastic, Jill. And then just last question. I know you had just mentioned just in terms of the -- just your sort of cash burn probably sort of increasing a little bit in 2019 over the second half of 2018 as Polaris and Galaxy ramp up. Could you, sort of, give any color around that, just how to think about that? And I know that, that's within in the context of having that cash on hand I guess till -- towards the end of 2020, just any thoughts there?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [9]

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Yes, thanks, Hartaj. Yes, so as we indicated, it will -- with Polaris ramping up and the Galaxy open-label extension trial ramping up, we expect the quarterly burn to be a little bit higher than it was in the last 2 quarters. What we have articulated is runway into Q4 of 2020 and that's probably a good framework to work from.

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Operator [10]

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Our next question Joel Beatty of Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [11]

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The first one is on the MoveDMD extension trial. Just curious about a status update on it, if it's still ongoing or how many patients are in it? And the potential for any additional data from that extension trial?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [12]

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Yes. So the MoveDMD open-label extension trial remains ongoing. And as Joanne indicated in her part of the discussion today, those boys are being moved into our GalaxyDMD trial, so we'll have a unified open-label extension going forward. So the boys from the Phase III will go into Galaxy as well as the MoveDMD boys. So we're -- boys from MoveDMD will remain on treatment for as long as they, their families and treating physician thinks it's appropriate. And in terms of data update, so Joanne just gave an update at a conference just last month, going forward, as we've indicated, the data will largely be safety data. And really the purpose of GalaxyDMD and the open-label extension, both from MoveDMD and, ultimately, for Polaris will be for collecting long-term safety data as well as getting experience in older boys with Duchenne to support a future potential registration.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [13]

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Got it. And then for the Phase III PolarisDMD trial, in DMD there's often a lot of variability between patients. So I'm curious what you -- are you able to do to -- maybe just the variability on the primary endpoint of NSAA, to try to be able to have be it more powered to (inaudible) the benefit of edasalonexent.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [14]

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Yes, I'll let Joanne answer that question. And I think it really speaks to the age range of boys we're enrolling and the enrollment criteria to try to minimize as much as possible, the variability at baseline of the boys entering the trial.

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Joanne M. Donovan, Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development [15]

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Yes, we did change the enrollment criteria for time to stand, it required them to be below 10 seconds to decrease the variability. And in terms of our analysis, we'll also be controlling for variables that affect the outcome. So we are -- that allows us to maximize the power of the study with the existing enrollment.

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Operator [16]

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Ladies and gentlemen, this includes today's question-and-answer session. I would now like to turn the call back over to Jill Milne for any closing remarks.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [17]

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Thank you, Hailey. Thank you, all, for joining our call this morning and for your continued support of Catabasis. We will keep you updated as we execute on our Phase III PolarisDMD trial for edasalonexent and share other areas of progress. We look forward to speaking with you again soon. Andrea?

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Andrea L. Matthews, Catabasis Pharmaceuticals, Inc. - VP of Corporate Affairs [18]

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That concludes today's call. A webcast replay will be available for 90 days via the Investor Relations page on our website at www.catabasis.com. Thank you.

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Operator [19]

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Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program, and you may all disconnect. Have a great day.