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Edited Transcript of CATB earnings conference call or presentation 10-Mar-20 12:30pm GMT

Q4 2019 Catabasis Pharmaceuticals Inc Earnings Call

CAMBRIDGE Mar 27, 2020 (Thomson StreetEvents) -- Edited Transcript of Catabasis Pharmaceuticals Inc earnings conference call or presentation Tuesday, March 10, 2020 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 A. Komjathy

Catabasis Pharmaceuticals, Inc. - Chief Commercial Officer

* Andrew J. Nichols

Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer

* 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

* Noah Clauser

Catabasis Pharmaceuticals, Inc. - VP of Finance & Principal Financial Officer

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Conference Call Participants

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* Hartaj Singh

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

* Vasiliana Vireen Moussatos

Wedbush Securities Inc., Research Division - MD of Equity Research

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2019 Catabasis Pharmaceuticals, Inc. Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker today, Andrea Matthews, Vice President, Corporate Affairs. Please go ahead, ma'am.

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

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Thank you, Josh. Welcome to today's Catabasis Pharmaceuticals conference call, where we will provide a corporate update and review our fourth quarter and full year 2019 financial results. With me today are Jill Milne, Chief Executive Officer; Joanne Donovan, Chief Medical Officer; Andrew Komjathy, Chief Commercial 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 2019 financial results, which we will reference on today's call and 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 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 2 ongoing clinical trials with edasalonexent, the Phase III PolarisDMD trial and the open-label extension GalaxyDMD trial. Andrew will review the potential market opportunity for edasalonexent in Duchenne, and Andy will share an update on our preclinical work. Noah will provide a financial summary, and we will open for questions.

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 for today's call. We made excellent progress at Catabasis with our edasalonexent program in 2019. We believe that our product candidate, edasalonexent can be a foundational therapy for all patients affected by Duchenne muscular dystrophy. We are looking forward to the results from the Phase III PolarisDMD trial this year. The Phase III PolarisDMD trial in Duchenne is fully enrolled, and we are preparing for top line Phase III results in the fourth quarter of this year and a subsequent NDA filing in 2021. We have commercialization and supply chain preparations underway and recently strengthened our financial position. Based on our current operating plan, we expect to be able to fund operations through a potential NDA filing and into Q3 2021.

For those that are less familiar with Catabasis, we are taking a different approach to treating Duchenne than other development programs. Edasalonexent was designed to inhibit NF-kappa-B, a mechanism with the potential to benefit all patients with Duchenne, and therefore, is not limited to patients with specific mutations. It is important to remember that in Duchenne, the absence of the dystrophin protein is necessary, but not sufficient to drive disease progression. Typically, young boys with Duchenne are not symptomatic in their first couple of years. However, without dystrophin, mechanical stress from everyday activities like running, chronically activates NF-kappa-B, which leads to progressive deterioration of skeletal muscle. Importantly, the chronic activation of NF-kappa-B is also a critical component of cardiac disease and a factor in bone health in Duchenne. By inhibiting NF-kappa-B, we believe edasalonexent can have broad therapeutic effects and benefit all patients with Duchenne, regardless of mutation, both as a monotherapy as well as in combination with dystrophin-targeted therapies. Based on our clinical data and the mechanism of action, edasalonexent has the potential to benefit skeletal muscle including the diaphragm, cardiac function and also bone health. We believe that a recent analysis of the baseline characteristics of the patients enrolled in the Phase III trial supports the assumptions on which the Phase III trial was powered. The analysis compared the baseline characteristics of the patients enrolled in our Phase III trial to the patients enrolled in our previous Phase II MoveDMD trial and found, overall, similar characteristics in the patient populations in the 2 trials. Joanne will talk more about this shortly, and we'll also be presenting the baseline characteristics at the upcoming 2020 MDA Clinical & Scientific Conference later this month.

We are also working in multiple areas to maximize the potential of edasalonexent, both in Duchenne as well as in additional neuromuscular diseases. We are excited to have entered into a partnership with the leading European patient advocacy organization, Duchenne UK to explore edasalonexent in nonambulatory patients with Duchenne. We see this as important for the future, both in terms of the needs of this patient population as well as to generate data in older boys and men to improve future access. We see edasalonexent as an attractive commercial opportunity in Duchenne, and Andrew will elaborate on this. We have also made great progress in the preclinical research on the potential benefits of edasalonexent in Duchenne and additional neuromuscular diseases, as Andy will review today.

Before we move to our clinical and other updates, I want to note that going forward, we are going to reserve conference calls for clinical data and significant events and are not planning to host regular quarterly earnings calls. We will continue our frequent communication practices and remain available for questions.

With that, I'll turn the call over to Joanne to provide an update on our ongoing clinical trials and upcoming plans. 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. Our fully enrolled Phase III PolarisDMD trial of edasalonexent is progressing well. In less than a year, we enrolled 131 boys affected by Duchenne in 8 countries across the world due to strong interest from physicians and Duchenne families as well as support from patient advocacy organizations. Thank you to everyone who is making this global Phase III trial possible, including all participating families and the clinical trial site staff.

As you likely recall, the Phase III PolarisDMD trial is a randomized, double-blind, placebo-controlled trial with 2:1 randomization. The primary efficacy endpoint is the 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 with support from regulatory authorities. Key secondary endpoints include the time function test, 10-meter walk run, time to stand and 4-stair climb, and additional assessments include growth, cardiac and bone measures as well as patient-reported outcomes. We expect top line results from the Phase III PolarisDMD trial in the fourth quarter of this year, and the trial is anticipated to support an NDA filing next year.

As Jill mentioned, following the completion of enrollment, we conducted an analysis of the baseline age and functional test performance of the patients enrolled in the Phase III trial as compared to the patients enrolled in the previous Phase II MoveDMD trial and found no significant differences in the baseline characteristics of the patient populations in the 2 trials. We believe that these findings support the assumptions on which we power the Phase III trial. The patient population in both trials is also similar to published natural history studies of boys in this age range that are not on steroids. To summarize the patient populations, both trials enrolled boys aged 4 to 7, up to their 8th birthday, with any mutation type who had not been on steroids for the previous 6 months. The Phase III trial enrolled the 131 boys at 37 sites in the United States, Canada, Europe, Israel and Australia. And 98% had never been on steroids. All 31 boys that enrolled in the Phase II trial were enrolled in the United States and had never been on steroids. We will be sharing more information on the Phase III baseline characteristics as well as the reproducibility of North Star in this patient population at upcoming scientific conferences. Our open-label extension trial GalaxyDMD embodies our ongoing commitment to the Duchenne community. Our primary objective with this trial is to collect long-term safety data, and we're also monitoring assessments of muscle function as well as bone health. Clinic visits and assessments are conducted every 6 months for this trial. Boys who have completed treatment in the Phase III PolarisDMD trial have enrolled in the GalaxyDMD trial and their eligible siblings, up to age 12, have the option to enroll as well. We've seen an excellent rate of enrollment in GalaxyDMD from the Phase III trial and all boys are receiving open-label edasalonexent.

Boys in the GalaxyDMD trial that are amenable, are also able to initiate co-administration of approved exon skipping therapies. Earlier this year, we were thrilled to announce our partnership with the patient advocacy organization, Duchenne UK to evaluate edasalonexent in a Phase II trial in nonambulatory patients with Duchenne. We recognize the need for a well-tolerated treatment for all patient populations that has the potential to slow disease progression and to preserve muscle function by benefiting both skeletal muscle as well as cardiac function. Duchenne UK granted us over $600,000 in funding to support patient and clinical trial site costs. We're incredibly fortunate to have the opportunity to partner with Duchenne UK for this important work and appreciate their deep commitment as we work together to bring treatment options to all patients. This Phase II trial is planned to assess safety, pharmacokinetics and exploratory measures, including cardiac, skeletal muscle and pulmonary function in nonambulatory Duchenne patients. The Phase II trial is designed to be a 1-year randomized, double-blind, placebo-controlled trial in nonambulatory boys and then affected by Duchenne. We are working on the final clinical trial design with investigators and look forward to sharing more details about the trial plans in the coming months.

I'll now pass the call over to Andrew to discuss the potential commercial opportunity with edasalonexent in Duchenne. Andrew?

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Andrew A. Komjathy, Catabasis Pharmaceuticals, Inc. - Chief Commercial Officer [5]

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Thank you, Joanne, and I'm happy to share my perspective on what we believe is a very attractive commercial opportunity for edasalonexent in Duchenne. Edasalonexent has the potential to provide clinical benefit broadly and serve as a foundational treatment for all Duchenne patients from the time of diagnosis onwards, regardless of mutation type. There remains a high unmet need in Duchenne, with an estimated 15,000 boys and men living with Duchenne in the U.S. today and approximately 19,000 in Europe with very few approved therapies, most of which are not amenable to the whole patient population and with no cure available. Unlike most rare diseases, Duchenne is an attractive commercial opportunity due to the fact that most patients have already been identified and diagnosed, and that the majority of patients in both the U.S. and EU are treated at highly concentrated sets of clinical treatment centers, which can be supported by a focused sales force and medical affairs team.

In order to better understand the substantial unmet need in Duchenne, we conducted primary blinded market research with U.S. and EU providers and payers, which confirmed their high interest in a product like edasalonexent. The most encouraging signal was that the vast majority of physicians participating in the research indicated a strong interest in using edasalonexent based on the efficacy and safety profile available at the time of research. Both providers and payers like the Phase III design and the endpoints. Additionally, the payers interviewed agreed that edasalonexent's potential clinical benefit would justify innovative orphan drug pricing in Duchenne. Overall, we were very pleased and encouraged by the responses and feedback in both the U.S. and EU.

We also see the planned Phase II non-ambulatory trial in partnership with Duchenne UK as providing important data for future market access, given that approximately 60% of those affected by Duchenne are nonambulatory and very underserved by current approaches. We also performed market research with patient advocates, parents and caregivers, and they were also enthusiastic about the prospect of edasalonexent as a treatment for Duchenne. The Duchenne community is eager to embrace edasalonexent, should it be approved by regulators, and we look forward to working with the community as we prepare for the potential commercialization of edasalonexent. Our commercial plans are underway. And as stated previously, we plan to commercialize edasalonexent ourselves in the U.S. first. We see edasalonexent as having global potential as a therapy and are evaluating our commercialization strategy outside the U.S. We look forward to updating you on the overall plans in the coming months.

Next, Andy Nichols will share updates from our research collaborations. Andy?

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Andrew J. Nichols, Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer [6]

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Thank you, Andrew. Our research program has been focused on establishing the potential for broad therapeutic benefits of edasalonexent in Duchenne and the potential for benefits in other neuromuscular diseases.

We've had great progress in our preclinical research programs recently. One of our collaborators is Dr. Pradeep Mammen, the Founder and Medical Director of the Neuromuscular Cardiomyopathy Clinic at UT Southwestern as well as Co-Director of the NIH-sponsored UT Southwestern Wellstone Muscular Dystrophy Cooperative Research Center. The mission of this center is to rapidly translate discoveries at the bench into therapies for Duchenne and Becker in the clinic. Our collaboration was designed to explore the potential of edasalonexent to reduce cardiac fibrosis and improve cardiac function in Duchenne and Becker muscular dystrophies. Our collaboration has been very successful, and we will be showing exciting results from this work at the end of the month at the 2020 MDA Clinical & Scientific Conference in Orlando.

We're also pleased with the progress of our collaboration with the Jain Foundation in dysferlinopathy, which includes limb-girdle muscular dystrophy type 2B and Miyoshi Myopathy. The initial preclinical data with edasalonexent in the mouse model of dysferlinopathy are encouraging, and we are continuing the study. We plan to present these results at a future scientific conference. In addition to our work to establish the potential for broad benefits of edasalonexent, we are on track in our preparations for an NDA filing for edasalonexent in 2021 and establishing our commercial supply chain.

I will now pass the call over to Noah Clauser to share our financial update. Noah?

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Noah Clauser, Catabasis Pharmaceuticals, Inc. - VP of Finance & Principal Financial Officer [7]

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Thanks, Andy, and good morning, everyone. Turning to our financials. Our fourth quarter and full year 2019 press release and 10-K provide the details, so I will provide a brief summary. As of December 31, 2019, we had $36.2 million of cash, cash equivalents and short-term investments. Following December 31, 2019, we raised an additional $25.6 million in net proceeds from equity financing. Based on our current operating plan, we expect to be able to fund operations through a potential NDA filing and into Q3 2021.

Our net cash used in operating activities was $7.8 million for the fourth quarter of 2019 and $26.6 million for the full year 2019. Our R&D expense was $4.3 million in Q4 2019 and $18.3 million for the full year 2019 compared to $3.7 million in Q4 2018 and $17 million for the full year 2018. Our G&A expense was $2.5 million in the fourth quarter of 2019 and $8.8 million for the full year 2019 compared to $2.4 million in the fourth quarter of 2018 and $9.3 million for the full year 2018.

Our operating loss was $6.7 million in Q4 2019, an increase of $0.6 million versus Q4 2018. Our net loss was $6.6 million or $0.55 per share in Q4, an increase of $0.5 million compared to our net loss in Q4 2018. Net loss for the full year 2019 was $26.3 million compared to $25.9 million for the full year 2018.

For the fourth quarter, we had weighted average common shares outstanding of $12.4 million. Looking forward, we expect our quarterly net losses to be higher than Q4 2019. We anticipate net losses to increase over the course of 2020 due to the ongoing Phase III PolarisDMD trial, the increasing number of patients in the GalaxyDMD trial and additional activities to support a potential NDA submission and our commercial preparations.

I will now turn the call over to Josh to open for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Liana Moussatos with Wedbush Securities.

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Vasiliana Vireen Moussatos, Wedbush Securities Inc., Research Division - MD of Equity Research [2]

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Congratulations on all your progress. About how many of the 131 PolarisDMD boys are now in Galaxy?

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

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This is Jill. That's a good question. So we are obviously announcing -- we had announced completion of enrollment in the Polaris Phase III trial back in September of 2019. And then, of course, had boys of -- accrued over the previous approximately 1 year. And so we haven't -- that number is changing as you might imagine, on a very regular basis, on a weekly basis. And so we don't have an exact number, I believe, at the moment to share. Joanne, do you want to add anything to how Galaxy is running?

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

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We had a good rate of enrollment in Galaxy coming out from Polaris, and we are moving along. But we certainly had a good enrollment through the second quarter and third quarter of last year.

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Vasiliana Vireen Moussatos, Wedbush Securities Inc., Research Division - MD of Equity Research [5]

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Would you say about half the patients are in Galaxy now? Less or more than half?

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Joanne M. Donovan, Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development [6]

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No, it's just that the number is changing. So I'd rather not say a number because I don't have it at my fingertips.

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

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And it is actively in the ramp-up phase, as you might imagine.

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Vasiliana Vireen Moussatos, Wedbush Securities Inc., Research Division - MD of Equity Research [8]

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Yes. And my next question, if your medical conferences that you want to present data at are canceled because of coronavirus. What's the backup plan of getting the data out there?

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

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That is a great question. And as you can imagine, one that we have been discussing on a very regular basis internally at Catabasis because this is a season with multiple scientific conferences where we do intend to be presenting updates. And so I don't have a definite answer for you now, but we are actively considering that, and trying to identify the best way forward to make sure that we can release updates on the data.

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Vasiliana Vireen Moussatos, Wedbush Securities Inc., Research Division - MD of Equity Research [10]

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And my last question is, is there -- have -- at your trial sites, have any of the health care professionals or patients been infected with coronavirus? Or is there any kind of new procedures to take care of them?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [11]

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So we are -- as you would imagine, we're actively monitoring the coronavirus situation, and we do have plans in place to address any potential disruptions.

I'll let Joanne address the question of whether, to our knowledge, there are any patients infected or investigators?

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Joanne M. Donovan, Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development [12]

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We don't -- we're not aware of anyone close to the trial. The -- I think that one of the things to remember is that the patients come in every 3 months, so that we are -- have a bit more flexibility than some trials do. And that's because of the safety profile we've seen to date.

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Operator [13]

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Our next question comes from Hartaj Singh with Oppenheimer.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [14]

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Like Liana, I congratulate you on your process -- sorry, on your progress and process. So just a couple of questions, sort of thinking ahead. One is, you've indicated that you're moving forward with the initial commercialization and supply chain prep. Can you just talk a little bit about what that is? Will you be using a CMO? Will you manufacture the commercial drug supply yourself? Where are you between the clinical to commercial CMC kind of tech transfer process? Or are you already there, commercial? Can you just talk a little bit about that? And then I just have a couple of follow-up questions.

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Andrew J. Nichols, Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer [15]

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So we have not actually disclosed and discussed our supply chain plans and plans for commercialization. But as you know, we actually do not have any physical capabilities of manufacturing ourselves. And like most companies, we use third-party providers to produce and distribute clinical supply materials and we'll also be doing that with our commercial materials.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [16]

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Great. Fantastic. Then just in terms of -- when you're looking forward to filing the NDA, I know that part of the NDA is some long-term animal tox studies that are ongoing even after the IND is filed and the preclinical work is done. Is all that complete or closing -- close to completion? Just how are you progressing in that regard?

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Andrew J. Nichols, Catabasis Pharmaceuticals, Inc. - Chief Scientific Officer [17]

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So we're progressing very well with all the nonclinical toxicology programs that are required for filing an NDA. And we do not see that as an issue at all.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [18]

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Great. Fantastic. Then just a question. You had mentioned that with your current primary research there's a potential that the drug's risk-benefit profile could support a orphan-like pricing strategy and this is a question, we just are asking more companies more frequently now because ICER has become, I think, important in the drug pricing firmament. So any thoughts about approaching ICER? I'm thinking about working with them prior to a launch for edasal?

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [19]

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That's a great question and something that we have under consideration and we'll certainly elaborate on more as we get closer. We do feel -- it's a little early for us to be talking about pricing per se, but we do believe that edasalonexent has the potential to be a very valuable addition to the treatment paradigm in Duchenne.

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Andrew A. Komjathy, Catabasis Pharmaceuticals, Inc. - Chief Commercial Officer [20]

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Yes. The only other thing I might add, too, is that one of the other thing that we learned in the research in both the U.S. and EU is the payers are still going to defer to the key opinion leaders on their advice and the risk-benefit associated with products like edasalonexent. So we're going to continue to maintain that dialogue, not only with payers but also with KOLs, both in the U.S. and in Europe.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [21]

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Great. Fantastic. And then just a couple -- just a follow-up on Liana's question, which is that -- let me ask you about Galaxy a different way, which is that, what's the total number of patients that Galaxy's allowed to accrue, including the siblings of boys under the age of 12, et cetera?

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Joanne M. Donovan, Catabasis Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Clinical Development [22]

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And so I believe that ClinicalTrials.gov lists approximately 140 patients. And that is anticipated to encompass with flexibility because it's approximate. All of the patients in Polaris, a certain number of siblings, and we are aware of the siblings that are potential enrollees. So it would be everybody who is eligible.

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Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [23]

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Great, Joanne. And then my last question is just a housekeeping question on just the burn. I know you had indicated that the quarterly burn will increase going forward, which makes sense. It seems you've got about a 2/3, 1/3 split between R&D and G&A right now. Do you expect that to change, too, over the next 4 to 8 quarters? Just any color and thoughts there would help.

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Andrew A. Komjathy, Catabasis Pharmaceuticals, Inc. - Chief Commercial Officer [24]

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No is the short answer. I think that, that split that you described has been pretty consistent over our history and unlikely to change.

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Operator [25]

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And I'm not showing any further questions at this time. I would now like to turn the call back over to Jill Milne for any further remarks.

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Jill C. Milne, Catabasis Pharmaceuticals, Inc. - Co-Founder, CEO, President & Director [26]

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Thank you, Josh. And 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 [27]

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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 [28]

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Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.