Enanta Pharmaceuticals (NASDAQ:ENTA) Q3 2020 Earnings Call

0:00 Good afternoon and welcome to an ANTA Pharmaceuticals Fiscal Third Quarter conference call. At this time, all participants are in listen-only mode. There will be a question-and-answer session at the end of the prepared remarks. Please be advised that this call is being recorded. I will now turn the call over to Jennifer Viera, Senior Director, Investor Relations. Please go ahead.

0:25 Thank you, Operator, and thanks to everyone for joining us this afternoon. The news release with our financial results for the recent quarter was issued this afternoon and is available on our website. On the call today is Dr. Jay Luly, President and Chief Executive Officer, Paul Mellet, our Chief Financial Officer, and other members of Enanta's senior management team. Before we begin with our formal remarks, I want to remind you that we will be making forward-looking statements, which may include our plans and expectations With respect to our product candidates and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements.

1:14 A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. Enanta does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to Dr. Jay Luly, President and CEO. Jay?

1:34 Thank you, Jennifer. Good afternoon, everyone. Thank you for joining us today. I'm pleased to report the progress we've made during the quarter across our pipeline, which is focused on our two areas of expertise, virology and liver disease, with programs in respiratory syncytial virus, hepatitis B virus, human metanemovirus, SARS-CoV-2, and non-alcoholic steatohepatitis. On this call, I will discuss clinical and preclinical updates across our pipeline, and Paul will review the financials for the quarter. Before I get into my formal remarks, I want to take a moment to welcome Mark Folletta, whose appointment we announced in June to our board of directors.

2:20 We're very pleased to have Mark join our team, where he will serve as chair of the audit committee will be a member of the Nominating and Governance Committee. Mark has extensive financial, operating, and governance experience, previously serving as Chief Financial Officer for various biopharma companies, including Amelin Pharmaceuticals. Mark will be instrumental in helping us as we advance our pipeline of innovative treatments for viral infections and liver diseases. Additionally, I want to take a few moments to comment on the resiliency of our team here at Enantix. Despite the backdrop of the ongoing COVID-19 pandemic, the team has been able to stay focused and ensure that our business progresses and that our pipeline continues to mature.

3:06 We have clinical studies ongoing with three different compounds. We are preparing a fourth compound to move into the clinic this quarter, and we are continuing our work to develop candidates for human metapneumovirus and SARS-CoV-2. To that end, I'll begin with our virology-focused programs, where we are leveraging our antiviral drug discovery expertise to discover and develop multiple product candidates. I'll start with EDP514, our lead core inhibitor and our HPV program that is currently being tested in both viremic HPV patients and nuke-suppressed HPV patients. We are committed to developing a treatment for HPV as it is a disease with a true unmet need. It's estimated that HPV affects more than 250 million people worldwide.

3:59 In early July, we announced that we initiated our Phase 1B clinical trial in viremic HPV patients. This randomized, double-blind, placebo-controlled Phase 1B study in viremic chronic HPV subjects not currently on therapy is designed to evaluate the safety, tolerability, pharmacokinetics, and any viral activity of orally administered EDP514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP514 or placebo at our clinical trial sites in Hong Kong and Taiwan, which are both areas with a large unmet need for HPV treatment.

4:45 As we continue to monitor the impact of COVID-19 in these regions, We expect preliminary data from this trial in the first half of 2021. We've also resumed our ongoing randomized, double-blind, placebo-controlled Phase 1B study in chronic HPV patients treated with nucleoside reverse transcriptase inhibitors, which we refer to as nuke-suppressed patients. This study, which was paused in March due to the COVID-19 pandemic, is part two of our Phase 1A, 1B study. Part 2 is designed to evaluate the safety, colorability, pharmacokinetics, and antiviral activity of orally administered multiple ascending doses of EDP514 over a 28-day period.

5:34 The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP514 for a placebo. For any further COVID-19 disruptions, we plan to have preliminary data in the second quarter of 2021. As a reminder, we plan to present first in human data from part one of the phase one study in Healthy Volunteers in a poster presentation at EASL's Digital International Liver Congress being held August 27th through the 29th. Let's turn now to EDP938 and our program for respiratory syncytial virus, or RSV. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults at a condition for which there is currently no safe and effective therapy.

6:31 EDP938 is a potent non-fusion inhibitor of RSV-A and RSV-B, has been shown a significant reduction in viral load and symptom resolution in top-line data from a Phase II human challenge study. We are currently initiating sites in the southern hemisphere for RSVP, our ongoing Phase IIb study of EDP938, and are also keeping our existing North American sites ready for reactivation with the arrival of the fall and winter RSV season as well as adding a number of new sites in Europe. RSVP is a Phase IIb double-blind placebo-controlled study of EDP 938 designed to mill approximately 70 subjects up to the age of 75 years randomized to receive either 800 milligrams of EDP 938 or placebo for five days. The primary objective of the study is to evaluate the effect of EDP 938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period, and any viral efficacy will be evaluated as a key secondary endpoint.

7:48 Well, it's too early to know what impact COVID-19 will have on RSVP timelines. Assuming full study enrollment in the northern hemisphere this upcoming winter, we would expect to have data in the third quarter of 2021. Meanwhile, we are on track to initiate two additional Phase II studies with EDP938, one in pediatric patients and one in adult transplant patients, by the end of this year, concurrent with the RSVP study. The pediatric trial will be a Phase II randomized, double-blind, placebo-controlled, dose-ranging study of EDP938 to evaluate EDP938 regimens in hospitalized or non-hospitalized infants and children aged 28 days to 24 months who test positive for RSV based on an approved diagnostic assay.

8:43 The adult transplant study is a phase IIb randomized double-blind placebo-controlled study of EDP938 to evaluate the effect of EDP938 in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract. Turning to the rest of our virology franchise, we remain focused on developing a candidate for SARS-CoV-2. We are utilizing our core strength and compound optimization in drug development to understand the virus and identify vulnerabilities to exploit intracellular targets using, for example, protease inhibitors and polymerase inhibitors. These are direct-acting antivirals, often referred to as DAAs.

9:31 As with RSV, we believe these DAAs should be more effective than entry inhibitors in stopping the virus after patients already show symptoms of infection. Chemistry and biology efforts are actively ongoing, and we hope to make important progress throughout the remainder of the year. Moving on to our second emerging program, earlier this year we also introduced a drug discovery program for human metapneumovirus, also known as HMPV. Similar to RSV, HMPD is a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma.

10:16 We continue to perform optimization of our current nanomolar HMPD inhibitor leads and are aggressively working to identify our first clinical candidate for this indication. Shifting gears to our work in non-viral liver disease, Where we currently focus on NASH, we are conducting clinical studies of EDP305, our first FXR agonist. Based on data from Argon1, which will be highlighted in an oral presentation at EASL later this month, we initiated recruitment in Argon2 in July. Argon2 is a Phase IIb randomized, double-blind, placebo-controlled, 72-week study in approximately 340 subjects with biopsy-proven NASH. The primary endpoint of Argon-2 will be improvement of fibrosis without worsening of NASH and or NASH resolution without worsening of fibrosis.

11:12 We are using EDP-305 doses of 1.5 milligrams and 2 milligrams, which we selected to provide strong target engagement and a balanced profile in terms of efficacy and tolerability. Argonne 2 will include a 12-week interim analysis, which we are targeting for mid-year 2021, to assess that balance and to generate dose information more quickly for potential combinations with other mechanisms in NASH. We are additionally developing EDP297, our follow-on FXR agonist candidate for NASH. We're pleased to be on track to initiate a Phase 1 study of EDP297 later this quarter and expect data in the second quarter of 2021.

11:57 We're excited about EDP297, given compelling preclinical data that demonstrate its high potency and tissue targeting characteristics compared to other FXR agonists in development. Specifically, EDP297 is targeted to tissues important for efficacy, namely liver and intestine versus plasma and skin. We believe that a highly potent highly selective and tissue-targeted FXR agonists may allow for lower effective doses and an improved tolerability profile. We plan to present two posters on the preclinical profile of EDP297 at Edelpeat at Easel later this month.

12:43 I'd like to conclude my remarks by emphasizing a few key takeaways. We look forward to moving our HPV trial and viremic patients forward with preliminary data anticipated in the first half of 2021. We also look forward to preliminary results from our Phase 1b trial on HPV patients who are nuked suppressed by the second quarter of the year. We are pleased that the RSVP trial is continuing in the Southern Hemisphere. We are ready to return to sites in North America while adding additional sites in Europe during the coming fall and winter RSV season. We're also eager to begin our two other RSV studies on both pediatric patients and adult transplant patients next quarter.

13:30 And finally, we're excited about advancing our candidates in MASH, where we were able to initiate the Argonne 2 trial of EDP 305 and are on track to initiate the Phase 1 study of EDP 297 this quarter. I'll stop here and turn the call over to Paul to discuss our financials for the quarter. Paul?

13:51 Thank you, Jay. I'd like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today, we are reporting results for our third fiscal quarter into June 30th, 2020. For the quarter, total revenue was $18.7 million and consisted entirely of royalty revenue earned on Abbey's global HCV net sales of $376 million. This compares to total revenue of $44.4 million for the same period in 2019. The decrease in royalty revenue is a result of AbbVie's lower net sales, which were significantly affected worldwide by the decline in patient volumes due to the COVID-19 pandemic. AbbVie now expects HCV sales of approximately $2.1 billion for calendar year 2020, as treatments remain below pre-COVID levels.

14:45 Royalty revenue was calculated on 50% of Maverick sales at a royalty rate of 10%, after adjustments for certain contractual discounts, rebates, and set-offs, which are now just over 2% of AVI's total reported HCV sales. I'll remind everyone that our royalties, which are calculated separately for each product, are determined on a calendar year basis for a tiered schedule of rising royalty rates. The royalty schedule restarted at our lowest royalty rate of 10% in our quarter ending March 31. This means that royalties in the same amount of quarterly marriage sales would typically increase each quarter, with our royalties for the quarter ending December 31st having the highest blended royalty rate. You can review our royalty tier schedule in our 2019 Form 10-K.

15:38 Moving on to our expenses, for the three months ended June 30th, 2020, research and development expenses totaled $34.7 million, compared to $34.5 million for the same period in 2019. General and administrative expense for the quarter was $6.8 million compared to $6.2 million for the same period in 2019. This increase is due to an increase in compensation expense for the quarter. ANANTA recorded an income tax benefit of $7.1 million for the three months into June 30, 2020 compared to an income tax benefit of $0.9 million for the same period in 2019. The income tax benefit for the quarter was driven by our net loss for the period, federal research and development tax credits, and a federal net operating loss carryback.

16:27 An interest effective tax rate for the nine months ended June 30, 2020 was approximately 58% compared to less than 1% for the same period in 2019. The effective tax rate for 2020 reflects increasing federal research and development tax credits and a federal net operating loss carryback. Net loss for the three months ended June 30th, 2020 was 14.3 million or a loss of 71 cents per diluted common share compared to net income of 7 million or 33 cents per diluted common share for the corresponding period in 2019. And then at the end of the quarter with approximately 435 million in cash and marketable securities, an increase of approximately 35 million from our 2019 fiscal year end balance of 400.2 million.

17:17 We expect that these cash resources, as well as our continuing royalty revenue, will continue to be sufficient to meet our anticipated cash requirements for the foreseeable future. Further financial details are available in our press release and will be available on our Form 10-Q for the quarter when filed. I'd now like to turn the call back to the operator and open up the lines for questions. Operator? To ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from Eric Joseph with J.P. Morgan.

17:59 Hey, guys. Thanks for taking the questions. Just a couple from us, first on EBT 514. Jay, I'm just wondering if you could sort of frame expectations for us. in the Phase 1b in nuke-suppressed patients with data expected in the second quarter. How should we be thinking about data that would be establishing a go-forward dose regimen there, and what compelling results would look like in terms of viral Well, sorry, yeah, what the objectives there are in terms of establishing a go-forward dosing in that study. Thanks.

18:48 Sure. Thanks, Eric. So this is Trey. So, yeah, the nuke-suppressed study is one of the two that we have going on right now. And why don't I just actually compare and contrast a little bit as I answer the question so you get a player for both studies. They're both 28-day studies, but they're quite different. The nuke-suppressed folks are obviously on an existing nuke therapy, so their DNA levels are already going to be quite suppressed. They're both, as I mentioned, 28-day studies, so what you can get out of the nuke-suppressed study that's extremely important is actually safety and tolerability and PK in the context of a nuke. You know, as you know, nukes are the sort of the standard of care today for hep B treatment. And the study substantially is looking to make sure that 514, you know, plays well with nukes. So that's the main aim of this study. We'll, of course, also get other antiviral data from this, you know, RNA and That's antigen, e-antigen information. But not to expect too much there, given the 28-day

20:19 nature of the study. In the case of the viremic study, it's a little bit different. So we'll be, again, it's a 28-day study. We'll be looking at patients who haven't been on HPV Thank you. Thank you. Thank you. at Virologic Parameters as well. So DNA will be able to get RNA, S antigen, E antigen, and so forth. But it's really over a 28-day time period.

21:23 In terms of some sort of a range of what we would like to see in that viremic study, I'd say something that would give us a solid Two log decrease or more over that time period would be, I think, give us a sense that 514 is working well. So we'll be using all that information together to pick, you know, go forward doses.

21:56 Great. Thanks for taking the questions. Thank you. Your next question is from Brian Snorsky with Baird.

22:06 Hey, good afternoon, guys. Thanks for taking the question. Just when we sort of think about the Argonne trial design and post when we get that data, you know, kind of your thoughts on how you think about kind of phase three and what the regulatory hurdle is here. I mean, we've all seen OCA, the first FXR agonist, got a rejection by the FDA, although seemingly hitting what's within the FDA guidance. Just Interested in getting your thoughts, Jay, on your view of that outcome and how we should be thinking about the development of FXR for U.S. approval in the future. Thanks.

22:48 Sure. So, well, I think the community at large, you know, the KOLs and certainly Wall Street, some of... Intercept's competitors were actually all sort of surprised to see the complete response that are there. So I think we just need, regarding phase three studies, I think we just need to see, you know, more information, try to understand a little bit better, you know, what the FDA had in mind with regards to Intercept's package. Intercept, I understand, is having some meetings with the agencies. So over time, I think we'll get greater transparency as to what's going on there, what's happened there, and what may lay in the future for Intercept and for others.

23:44 So it's sort of a broad-ranging question that we'll just need to see how it plays out. But it's certainly a very intriguing development, to say the least, for us. You know, our path is pretty straightforward. You know, we're not in the middle or even starting a registration study at this point. So to the extent there are any goalposts that could move around a little bit or other ways that the regulatory path could be impacted here, you know, we'll have plenty of time to process that and incorporate it into future studies. So for us, for the Argonne study, Argonne 2. As you know, it's really about staring between goalposts of doses that we looked at in Argonne 1. We're bumping up the low dose, we're bringing down the top dose, and we know exactly what to look for vis-a-vis target engagement and also tolerability. So That's a fine tuning of a dose selection there. And again, we'll have an interim analysis that'll come along sort of mid next year where we'll have a pretty good sense of how those two doses behave and will give us good guidance for the future.

25:15 And then separately, you didn't ask about 297, but it's also The Molecule of the Same Class. It's tucking along very nicely on a parallel path, and our plan is to get that into phase one this quarter, and then to stare at the parameters that we know how to measure well, first in healthies, where we can look both at target engagement and tolerability, and then understand whether the thesis that we've generated in terms of the design of the follow-on FXR agent plays out in the clinic.

26:02 So that'll be exciting to watch, too, over the course of the next few quarters. And we expect data on 297 molecule in the second quarter of next year. Great. Thanks, Jeff.

26:17 You're welcome. Your next question is from Rory Buchanan with J&P Securities.

26:26 Hi, great. Thanks for taking the question. I had a handful on RSV. I'm just wondering if you'd give us some details for RSVP, how the southern hemisphere RSV season is looking, and can you tell us how many sites you're targeting for Europe? And I had a couple on the Phase II trials you're planning in pediatrics and the transplant patients. Are those going to be solely based in the U.S.? I have one follow-up.

26:51 So with regards to RSVP in the southern hemisphere, you know, it's just winter is just kicking up. You know, it's going to be really interesting to see how the southern hemisphere plays out. You know, it's a little bit of a different setting. You know, Australia and New Zealand opened up, you know, reasonably early. Thank you for joining us. Thank you for joining us.

28:18 Will it simply be a frame shift of a sort of a normal cold and flu season, an RSV season, or will it be, you know, somehow blunted a little bit? And, you know, we obviously can't know the answer to that. We'll have to wait and see how it plays out over the next few months. But, you know, we sort of anticipated that a little bit, you know, earlier this year when we were doing our planning, which is why we I think we're anticipating all toll with the U.S., Canada, and Europe. I think we'll have over 100 sites on that order. And we're Thank you for joining us.

29:45 have everything, including the testing equipment that we need to get the characterization done on the diagnostic front. I think you had a question on the peds. Does that answer your question?

30:01 No, that was great. No, that was perfect. The pediatric and the transplant trials, I was wondering if those are going to be solely US-based trials?

30:17 We'll be starting in the northern hemisphere, but ultimately we'll be adding on other ex-U.S. sites as well. Okay, great.

30:30 And then I actually had a follow-up, and you kind of answered it with your, I think, with the southern hemisphere answer, but the RSVC even in the U.S. this last year kind of dropped off quickly, and I was wondering if that was Possibly people getting tested for COVID and not following up when it was negative or the social distancing reducing the bystander effect.

30:51 It actually, you know, had sort of come and gone before COVID was a word. You know, that was the really surprising thing. Usually RSV in the Northern Hemisphere is peaking in the January, February timeframe, you know, sliding through March and maybe tailing into Q2. That's sort of the typical presentation. And for whatever reason, this last year was very strange. It peaked in December and then fell very quickly and unexpectedly. So I think that's a, you know, hopefully, you know, that's a bit of an anomaly, but either way.

31:38 The difference between this year and last year. Last year, as you know, we were just finishing up the challenge study and just getting the RSVP study up and running as fast as we could after data just by the end of the year. Figuring that January, February and into Q2 would be the big period, but pretty much gone this time. We still have all the sites that we had before. We've suggested we're supplementing that with a bunch of European sites and so forth. And then we'll get what we can down in the southern hemisphere.

32:23 So we'll just continue to watch it, but we're adding lots of sites.

32:30 Okay, great. Thanks for taking the questions. You're welcome. Your next question is from Brian Abrahams with RBC Capital Markets.

32:41 Hi, this is Leo on for Brian. Thanks for taking my question. I have one on the human pneumonia virus. So you guys have hinted at some of the leads you've identified. Can you remind us what the timelines are for this program to enter the clinic and perhaps what the ultimate opportunity you see for this program and how much work is going to need to be done to educate and other physicians and patients about this respiratory virus. And I guess, will there be any synergy with the RSV program there?

33:14 So, you know, thanks for the question. I was wondering if human virus would be picked up as a topic. It should be. You know, the reason everybody is certainly aware of RSV and the threat that it represents to a number of different patient populations, preying on the young and the old, the immune compromised and so forth. And in some years, RSV can be a big season, sort of rivaling in some patient populations what flu does. Human metanumo is sort of the second leading cause of everything that RSV causes.

34:00 It hits the same patient populations for the most part. Patients have pretty much the same presentation and the same sort of patient journey. It starts as an upper airway disease, can migrate to a lower airway disease. You can get pulmonary inflammation, cytokine storms, and so on. I think it's a little bit less known because it was sort of first characterized about 20 years ago. But if you hang out at the respiratory infection meetings, you actually see a lot of human metanuma there. So the medical community, people who treat patients are quite aware of this virus. And so I think it's the fact that it's relatively new and that, you know, there hasn't been sort of a new approach coming into human respiratory viruses lately until, you know, sort of EDP 938 came along, you know, sort of taking a different approach than what people had done in RSV with small molecules that I think there's going to be now, and add COVID on top of that, just a whole lot more Thank you so much for joining us.

35:45 Thank you very much. If you think about it from a commercial perspective, if you're building out a business on human respiratory viruses, if you're working on RSV, it makes an extraordinary amount of sense to be working on human metapneumovirus because, again, people are going to get diagnosed. And if it's one, you get one an antidrug. If it's another, you get another an antidrug.

36:34 And I think the only other company that's sort of really Thank you for joining us. Human Meta Neuro makes a lot of sense. Now, where are we? It's a drug discovery program. We announced it in January at J.P. Morgan. We've got nanomolar molecules that we like a lot, so I would say we're in the apple polishing stage.

37:27 The trick is doing what Ananta does pretty well and has done lots of times before, which is taking a really potent, interesting lead with strong virology and then optimizing all the other characteristics that you need to have a very successful clinical candidate. So it's at that interface now and hopefully we'll have something before too long. But again, we've got to check all of the boxes that we're doing. But I think it makes, again, a terrific amount of sense. It's a perfect complement to our other program.

38:04 Thank you.

38:06 You're welcome. And as a reminder, ladies and gentlemen, if you would like to ask a question at this time, simply press star then the number one on your telephone keypad. Your next question is from Jay Olson with Oppenheimer.

38:22 Oh, hi. Thank you for taking the question. I'm curious about the work you're doing on SARS-CoV-2. And I'm wondering if there's any recent research on the virus itself or any of the work that's been published on therapeutic antibodies or vaccines that has Thanks, Jay, for the question. So I'd say, you know, there's, mercifully, there are a lot of folks in the world, you know, trying to attack this problem.

38:48 And, you know, let's all hope that vaccines are successful and can treat as many Prophylax as many people as humanly possible. I'd say the vaccine approach is something that hasn't really informed our strategy at all. I know people, whether it's antibodies or vaccines, are thinking about spike proteins and other sorts of targets to generate interesting biologics.

39:36 What we're doing is something that's, you know, on the one hand, it's a bit different from what some other folks are doing out there, but it's very consistent if you've been following the thread on our respiratory viral programs with our approaches there. And that is, we assume that vaccine, no vaccine, partially effective vaccine, or some compliance, but not total compliance, there's always going to be people with infections, assuming that SARS-CoV-2 doesn't burn out. And right now, that doesn't seem as likely as people had once hoped.

40:23 So if you put yourself into that box and think, you know, a few years from now, There could still well be, even with vaccines around, a lot of important need for therapeutics and going after them in a very targeted way. So imagine if we could ever get to a state where we're treating people like we are in our RSVP trial, where people walk in, they present at a clinic, They're symptomatic. They get tested with an RT-PCR assay. It's determined that they have COVID or RSV or human metapneumo. And then they get put on a direct-acting antiviral, which can fairly rapidly, if other viruses, other respiratory viruses are some signal of this, you ought to be able to fairly rapidly knock that viral load down and then hopefully change the course of the person's infection.

41:25 And that's one of the exciting things we've shown with RSV is that from the time we put people on the drug, within 24 hours, it's really altered the course of the infection. That's what our challenge study showed. So if we can do that with COVID, you know, people can go home, people won't be You know, spreading, turning into super spreaders. They won't be infecting their family and relatives. And hopefully within a few days, you know, they can go back to work. So that's where we're aiming. Again, it's not a virus. It's not a vaccine. It's not a sort of an antibody treatment where you're going to have to go into and then fuse it or otherwise treat somebody who's very symptomatic with the biologic.

42:16 What we want to do is go early, hit hard with an oral regimen, and knock it down and think that that's going to be, if you follow where this is all going, it could well be an incredibly important opportunity out there that's not receiving as much attention as vaccines right now.

42:43 That's very helpful. Thank you, Jay. You're welcome. Your next question is from Akash Tiwari with Wolf Research.

42:56 Hi, this is Amy Lee. I'm for Akash. Thanks so much for taking our questions. Just had a couple on your RSV program. First, on your powering in RSVP, can you go over your assumptions in general and how you accounted for the differences in time to administration between the Phase 2a and Phase 2b, given that patients in Phase 2b will likely be administered drug later into the course of disease? Also, will your powering allow you to properly stratify for baseline factors and endpoints such as time to symptom onset, baseline viral titer, different cuts of symptom benefit, etc.? And then in regards to the pediatric and adult HSCT-RCP trials, will you also have a 48-hour symptom cutoff like RSVP? And what types of clinical endpoints would you be evaluating in these studies? Anything you can share on the design would be very helpful.

43:41 Thank you.

43:44 I'm sorry, anything to share on the design of the peds or transplant? Yes. Is that what you said? Yeah. So I'll start with that question first. I'm not sure we'll be able to dive in into all the different powering discussions right now. My biostatisticians aren't within immediate reach right now, but trust that the biostatisticians Statisticians have powered this in a way that, you know, looked very carefully at the challenge study, made further assumptions as it related to, you know, an outpatient study where we would be looking at somebody 48 hours, within 48 hours of symptoms, and powered the study according to those parameters.

44:37 In terms of the PEAD study, again, we're We're going to be looking at hospitalized or non-hospitalized infants and children. It'll be 28 days to 24 months of age. We'll be looking at safety, obviously, at the utmost, and PK. Those will be the things we'll be looking at early on, and we'll also be, of course, getting You know, virologic parameters as well. With regards to timing, as I recall, with the outpatient non-hospitalized subjects, we're going to be looking within a 48-hour time period.

45:27 And with regards to the hospitalized peds, I believe we've set a 72-hour time period. Looking over at the hematopoietic cell transplant folks, again, we're going to be recruiting people who have acute RSV infection of the upper respiratory tract. You know, we'll be looking to evaluate, you know, what the incidence is of lower respiratory tract complications, and we'll also have you know, secondary endpoints in there of safety and PK and we'll also be looking at virologic parameters as well.

46:15 I think in that, too, we'll be looking in transplant to, you know, for inclusion people who are within three days of symptoms. Okay, great. Thank you so much. These folks have obviously very compromised immune system and so You know, their symptoms can be quite persistent.

46:43 Great. Thank you.

46:44 You're welcome. There are no further questions in queue at this time. I'll now turn the call back over to Ms. Jennifer Viera.

46:56 Thank you, everyone, for joining us this afternoon. If you have any additional questions, please feel free to give us a call in the office or email me. Thanks again. Have a good evening. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.