Enanta Pharmaceuticals (NASDAQ:ENTA) Q1 2020 Earnings Call

0:00 Ladies and gentlemen, thank you for standing by and welcome to the Inanta Pharmaceuticals first quarter financial results conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to end the conference. Over to Ms. Carol Mussolini, Director of Investor Relations. Please go ahead, ma'am.

0:37 Thank you, Erica, and thanks for joining us this afternoon. The news release with our fiscal first quarter financial results was issued today and is available on our website. On the call today is Dr. Jay Luly, President and CEO, Paul Mallett, our Chief Financial Officer, and other members of the NANTA Senior Management Team. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline 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. A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. An answer 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.

1:30 Jay Luly, President and CEO.

1:32 Thank you, Carol. Good afternoon, everyone. On today's call, I will discuss our recent clinical development progress on our lead RSV, NASH, and HPV compounds and upcoming milestones to look for in 2020. I'll begin with ADP938, the only N inhibitor for RSV in clinical development today. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, and a condition for which there is currently no safe and effective therapy. At the end of 2019, we initiated our Phase IIb study named RSVP, which is a randomized, double-blind, placebo-controlled study of UDP938 Designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive either 800 milligrams of EDP938 or placebo for five days. The primary objective of the study is to evaluate the effect of EDP938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period.

2:44 Antiviral efficacy will be evaluated as a key secondary endpoint. We're pleased to report that we've been able to identify many adult outpatients who have had cold-like symptoms that started within 48 hours of their visit to an RSVP study site. Identification of RSV patients in this group has been aided by the prompt on-site confirmation of RSV infection, which we have been providing by PCR testing. Unfortunately, it appears that the North American RSV season this winter peaked in December, which is approximately one to two months earlier than in most years. As a result, we have seen fewer RSV cases than expected, and therefore we are planning to continue the study into the southern hemisphere and have enrollment continue in all sites, with the goal now to have data in the first half of 2021.

3:39 In addition to this study, we have also announced plans to initiate additional Phase II studies in pediatric patients and transplant patients by the end of this year concurrent with the RSVP study. We continue to believe that our end-protein inhibitor approach represents the best chance for success against RSV because it attacks the virus's replication machinery. Building on our success with viral infections such as HCV and our ongoing program with RSV, Last month, we introduced our newest drug discovery program, which is seeking therapeutics for human metapneumovirus, also known as HMPV. HMPV is a pathogen identified in 2001 that causes upper and lower respiratory tract infections in young children and the elderly, as well as in COPD, asthma, and immunocompromised patients. During 2020, we will continue to perform optimization of our current nanomolar inhibitor leads against this virus.

4:42 Now let's shift to HPV.

4:44 Our HPV program with EDP514 is moving ahead nicely, and today we announced positive results from the SAD and the MAD portion of our Phase 1 study in Healthy Volunteers. EDP514 is our novel Class 2 HPV core inhibitor, The aim of Part 1 of this randomized, double-blind, placebo-controlled, first-in-human study of EDP514 was to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses in healthy subjects, while Part 2 will assess the safety and antiviral activity of EDP514 and EDP514-1.

5:29 and new suppressed patients with chronic HPV infection.

5:33 Overall, EDP 514 in healthy subjects dosed for up to 14 days was well tolerated with a favorable safety profile.

5:42 Treatment emergent adverse events were infrequent and mild in intensity. No one discontinued EDP 514 due to adverse events, and there were no significant individual lab data findings or pattern of lab abnormalities. Additionally, the pharmacokinetic, or blood level profile, was fully supportive of once-daily dosing. Following these promising results, which support further clinical evaluation of EDP514 and HPV patients, Ananta has initiated a study in nuke-suppressed patients. These are patients with chronic HPV infection that is being suppressed with nucleoside reverse transcriptase treatment. We plan to enroll a total of 24 subjects among three escalating dose cohorts with study drug dosed for 28 days. Our goal is to have data from this study in the first quarter of calendar 2021.

6:39 Next quarter, we plan to initiate a separate study in HPV patients who are not on therapy and who have high levels of virus in their blood, who are also referred to as viremic. ADP514 was selected from our lead series of HPV compounds that are characterized by potent antiviral activity and promising preclinical data also support our excitement for ADP514 and for this mechanism. An abstract of the healthy volunteer portion of the study has recently been accepted for presentation at the International Liver Congress, known as EASL, so stay tuned for additional data in April. Switching to our NASH program, we are pleased to announce that the Argon 1 Phase 2A Proof of Concept Study of EDP305, our lead FXR agonist candidate, has been accepted as an oral presentation at EASL.

7:35 We plan to further evaluate EDP305 in Argon 2, a Phase 2B study in which we expect to initiate dosing by early next quarter. Argon 2 will be a randomized double-blind placebo-controlled 72-week study in approximately 340 subjects with biopsy proven NASH. The primary endpoint of the study will be improvement of fibrosis without worsening of NASH and or NASH resolution without worsening of fibrosis. We plan to use doses of 1.5 mg and 2 mg with the aim of demonstrating stronger biomarker signals of efficacy than seen at 1 mg in the Argon-1 study and less pruritus than seen at the 2.5 milligram in that study. The study will include a 12-week interim analysis to generate dose information more quickly for potential combinations with other mechanisms in NASH.

8:33 Also in our NASH program, Enanta has identified EDP297 as its follow-on FXR candidate. Preclinical data on EDP297 reveal a differentiated profile that delivers Thank you very much. This tissue targeting data showed that in preclinical models, EDP297 delivered the drug preferentially to tissues involved in FXR activity, namely liver and intestine, while minimizing drug levels in plasma and skin.

9:25 Two abstracts on EDP297 have been accepted and will be presented at the EASL conference in April. We believe that having a highly potent and highly targeted FXR agonist like EDP297 may allow for lower doses and reduced drug levels at non-targeted tissues, thereby potentially reducing pruritus, unless pruritus is FXR-mediated by FXR receptors in the liver or intestine. We plan to initiate a Phase I study of EDP-297 in mid-calendar 2020 and to have data in the first half of 2021. Lastly, the intrepid study of EDP-305 in PBC is completed dosing and we expect to announce top-line data by early next quarter.

10:15 So keep your eye out for presentation of Phase 1 results of EDP514 at Easel, the initiation of our Phase 1b study of EDP514 in viremic HPV patients, Phase 2 results of EDP305 in PBC, and initiation of our Phase 1 study of EDP297, all by mid-year. I'd like to close by summarizing a couple of key takeaways from today. First, that despite the vagaries of the RSV season in North America, we are advancing the RSVP study and have plans for two additional studies of EDP938 to start in other RSV patient populations later this year. And second, we had good safety and PK results with our lead HPV core inhibitor and healthy volunteers Leading us to initiate the second part of the study in nuke-suppressed HPV patients. This is all good progress.

11:12 We'll now turn the call over to Paul to discuss our financials for the quarter. Paul? 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 first quarter end of December 31, 2019. The quarter total revenue was $52.6 million. and consisted entirely of royalty revenue earned on Abbey's global HCV product sales. This compares to total revenue of $69.9 million for the same period in 2018. Royalty revenue is calculated on 50% of Maverick sales at a royalty rate for the quarter of 17% and on approximately 30% of Vicaris sales at a royalty rate of 10%. After adjustment for certain contractual discounts and rebates, which historically have been approximately 1.5% of AbbVie's total reported HCV product sales.

12:07 AbbVie will be reporting their global HCV sales number on February 7th. As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties for our fiscal first quarter ending December 31 will be calculated at the highest royalty rate and royalties for our fiscal quarter ended March 31st will be calculated at 10%, our lowest royalty rate tier in our fiscal year. We can review our royalty tier schedule in our 2019 Form 10-K. Moving on to expenses, for the three months ended December 31, 2019, research and development expenses totaled $32.8 million compared to $34.9 million for the same period in 2018. The decrease was primarily due to the timing of clinical trial costs associated With the progression of our wholly owned clinical programs in RSV, NASH, PBC, and HBV.

13:02 General and administrative expense for the quarter was $6.9 million, a slight decrease to the comparable quarter in 2018. An inter-recorded and income tax expense of $1.5 million for the three months ended December 31, 2019, compared to income tax expense of $3.7 million for the same period in 2018. Reflecting the reduction in income before income taxes. For the three months ended December 31, 2019, Ananta's effective tax rate was approximately 10%, compared to approximately 12.5% for the far-responding period in 2018. The reduction in rate was driven by both research and development credits, as well as a federal benefit from foreign-derived royalty income.

13:47 Net income for the three months ended December 31, 2019 was $13.4 million, or $0.65 per diluted common share, compared to a net income of $26 million or $1.25 per diluted common share for the corresponding period in 2018. And at the end of the quarter, with approximately $415 million in cash and marketable securities, an increase of approximately $15 million from our 2019 fiscal year end balance of $400 million. Further financial details are available in our press release and will be available in our quarterly report on Form 10Q when filed. I'd now like to turn the call back to the operator and open up the lines for questions. Operator? As a reminder, to ask a question, you will need to press star 1 on your telephone.

14:32 To withdraw your question, press the pound key. In the interest of time, we do ask that you limit yourself to one question and one follow-up so that everyone has a chance to ask their question. Please stand by while we compile the Q&A roster. Your first question is from Brian Abraham with RBC.

14:51 Hey guys, thanks so much for taking my questions. First off, on 938, the RSV program, I know you mentioned that you'll be getting the transplant and pediatric studies underway later this year. I was wondering if you could talk a little bit more about how you guys are thinking about the potential design there, and in particular, what's going to be shaping elements like the dose selection, potential duration, as you look to get those studies going later. And then I had a follow-up.

15:27 So thanks for the question, Brian. The team is working right now on the fine details of both of those studies. I'd say it's a little bit premature on this call to get into that. I'd say as the year progresses, we'll report more on RSVP and as the The exact design of these two new studies gels, we'll have a lot more to say about it then.

15:59 Okay, fair enough. And then it sounds like the HEPI program is moving along well with 514. I was wondering if you could maybe just elaborate a little bit more on what you guys observed in the Healthy Volunteer Phase 1 study with respect to PK and safety, your thoughts on the therapeutic window for that agent, and anything at least that you're able to glean from the Phase 1 study that might support your view of this being differentiated from others in the same class in development. Thanks.

16:36 I'll just start with a little bit of the preclinical background on 5142 first. So 514, you know, we worked a long time to identify this candidate and PICTA, we believe it's, you know, has, you know, a great preclinical profile, not only in terms of virology, both in vitro and in vivo, where it certainly looks better than first generation Capsid, or Core Capsid Inhibitors. You know, everything about that preclinical profile, including the pharmacokinetic profile across multiple different species, suggested that it had a pretty good chance of having a strong profile clinically, too. So, you know, we'll have a lot of details around this data set presented formally at EASL, but suffice it to say, It was generally safe and well tolerated.

17:38 Again, nothing remarkable in terms of any findings. And importantly, and as you know, the PK is really all important when you're looking at virals. And so we think we've got good exposures and good troughs and so forth that would give us a good amount of pressure So this is a 14-day study, and it's unhealthy, but we'll lay it out very clearly with all the details at EASL. But the results are definitely strong.

18:22 Great. Thanks very much, Jay.

18:24 You're welcome. Your next question is from Eric Joseph with J.P. Morgan.

18:30 Hi. Thanks for taking the question. A couple from me, first on 514. I guess I'm thinking about the Phase 1B study portion in muke-suppressed patients. If I heard correctly, this would be a MAD study assessing 514 over a 28-day treatment period. Can you talk a little bit about sort of the study objectives in that trial portion? How are you looking at... Antiviral Activity. Can you walk us through sort of the surrogates for efficacy looking at seroconversion or PGRNA?

19:10 Yeah, again, I'll remind you that this is a Phase 1b 28-day study, so it's a short-term study where we'll be looking, you know, principally at safety as primary endpoint, but I'll let Natalie comment on and some of the other aspects related to other things we'll be studying. Yeah, hi. Thank you for your question. So I think just to echo what Jay said, this is the second part of a first in-man study. So the 1B will be looking, obviously, at new surprise subjects, safety, PKR, the key primary and secondary objectives. We will be also looking at exploratory endpoints that, you know, All the other companies, I would say, you know, in that field are looking. Just to remind you that so far all those endpoints, enduramic patients or new surprise are still considered exploratory in essence. So we will be looking at, you know, something such as HBV DNA, HBV RNA, and other. And we will report that as we are obviously finalizing the study.

20:29 Great. And maybe just a separate question on the RSVP study. I just wanted to revisit the trial design empowering assumptions there. Can you kind of just talk about what the trial is powered to detect in terms of total symptom reduction versus no treatment? And I'm also curious to know whether looking at some of the flu antiviral programs are useful comps in terms of thinking about longer-term study design and whether, if that's appropriate, looking at time-distance, whether or not you're looking at time-distance symptom resolution. Thanks. So I think I heard very clearly your first question about the power of the RSVP study. I'm not sure I completely understood the second part, but maybe you can repeat once I address the first part.

21:20 So I think we had had that question a few times, beginning the power of RSVP study. We have, as you know, run a challenge study, and that was what we used as far as understanding our drug in context of the patient who received the placebo in the challenge study. to really identify and analyze clearly how the dynamic of symptoms was evolving over time. I'm not yet ready to disclose completely our report of the study, as I think it's more relevant when you present the data, but obviously we will be looking at seeing the difference of the progression of the symptoms from time to onset over 14 days course of study conduct.

22:16 I know it's an indirect way of responding, but that's what can I offer today. Would you remind me the second part of your question, please?

22:25 Sure. I'm curious to know whether you're looking at time to symptom resolution, specifically in the RSVP study, and the reason for asking the question is that that is an endpoint used in the influenza antiviral studies and I'm wondering whether that is a useful comparator set of studies to look at in thinking about longer term development of the pivotal development potentially of the EDP 938. Thanks. Yes, thank you. I appreciate your question. So obviously we have looked at Many of other flu studies to understand endpoints and symptoms in relationship to, you know, that patient population.

23:14 There's a series of key secondary endpoints as we'll be looking at more details, time to resolution, time to progression. There will be, obviously, you know, more detailed analyses of all the symptoms.

23:29 Great. Thanks for taking the questions. You're welcome. Our next question is from Yasmine Rahimi with Roth Capital.

23:41 Hi, team. Paul on for Yasmine. Thanks for taking my question. So, first, I just wanted to ask about, again, about RSVP. Can you talk more about the confirmation of RSV diagnosis and the optimal window for the study? And can PCR be used to determine quantitatively if patients' viral loads fall in the optimal range for intervention? So, we are using VAPI test and it's a PCR when the patient show up at the clinic within the 48 hours of the window. So, it's confirmed at the site and there will be a centralized also PCR that we do afterward.

24:24 Okay. Okay. And just one more question. Can you give some more color on what the profile for a Verisimic patient would look like in the next portion of the EDP514 study? Say that one more time, please.

24:40 I was wondering what the profile for viremic patient in the next portion of the EDP 514 study would look like. The profile of the viremic? The profile of the, for 514, for the HBV. Okay, sorry, I didn't, you switched to the HBV. So there will be patients who are viremic, or you see rather higher level of HBV DNA than the nukes suppressed, They could be either naive of treatment or they could have received treatment but having a, you know, a window where they don't receive any treatment. But they have to show an elevated level of HBV DNA at entry.

25:23 Gotcha. Okay, thanks so much. You're welcome. Your next question is from Akash Sawari with Wolf Research.

25:33 Hey, guys. So maybe on the RSV trial, maybe a little bit of color on why you chose AUC symptom benefit as your Phase IIb primary endpoint versus maybe like baseline viral load or something they use in Phase I or some of the flu trials. Would love to get some detail on that. Additionally, In your protocol, you say that patients will have to present within 48 hours of symptom onset. Are there any tricks that you're using for the trial to kind of ensure that patients are actually presenting within that treatment timeline? And finally, it seems like you're – I think you had previously mentioned that the powering was going to be similar to Phase 1, so I think that was around 80% powered.

26:19 Is there a chance that you could increase your enrollment now that the trial is getting pushed to first half 21? Thanks

26:30 so much. So I don't think there are any special tricks. I think we're taking people as they present, and we have to rely on the reliability of what they say in terms of symptoms. Obviously, they're the only people who can know. But the good news is we're seeing lots of people coming in within that time window with symptoms.

26:54 The

26:57 Could you repeat your first question, the first part of your first question again? Yeah, absolutely.

27:02 So, I think we were looking at, like, J&J's outpatient RSV phase 2, their pilot trial, and they're looking at a lot of primary and secondary endpoints, biokinetics, radiative symptoms. So, why specifically, it's an interesting endpoint, AUC symptom benefit as your primary endpoint, does it somehow give you a bit more wiggle room than some of these other and other exploratory endpoints that other companies are looking at. I think the choice of the AUC as far as the primary endpoint to look into the total symptom score was mainly driven also to the understanding and the very thorough analysis of our challenge study.

27:47 As we work with our statistician, We thought that AUC for symptom score will be a better endpoint for what we are looking for in the context of that study.

28:03 Got it.

28:04 It's also easier on an outpatient basis to get more data points because people will be reporting symptoms and diaries, etc., so Just from a practical basis on an outpatient study, you can get more data sampling that way. Just want to compliment to what Jay said about the trick. I mean, there's obviously a lot of work that went into educating the site and the site educating patients that come to see them. We are using family practice, emergency care, Center with patients with allergies, asthma, COPD. So we have launched a large campaign that tries to attract patients with clear understanding of the eligibility criteria for our study.

29:03 So we were able to be successful in that sense to attract patients with symptoms within our window.

29:11 Got it. And just a quick question. Given the trial delay on the RSV side, is there any chance that you'd be looking at increasing the enrollment so suddenly you might have more of a flu-like total number of patients in your trial versus something more in line with other RSV face-to-face studies? There's no plan to increase the enrollment number.

29:36 Got it. Thank you. Really appreciate it. You're welcome. Your next question is from Lisa Beko with J&P Security.

29:47 Hi there. Just wondering if you're going to be doing any interim cuts of the RSVP study. I thought that you needed some data in adult patients before moving into pediatrics, so just wondering how that's all going to work and if you're still then on time to start

30:06 at the end of this year. No, they're not. They're not really interrelated, and there won't be an interim cut. So, you know, we'll take the wealth of all the information we have and, you know, all the adults who have received study drug and, you know, parlay that into our thinking about how we dose peds, you know, ultimately. But, you know, our expectation is that these studies would be run concurrently.

30:38 Okay, so FDA doesn't need to see the data in the adult population before starting the pediatric study?

30:45 No. Okay, okay, got it.

30:48 And then could you maybe talk a little bit more about the differentiated profile of 297? As you mentioned, it was differentiated, and I'd just be curious. I'm learning a little bit more about that.

30:57 Thank you. Sure. So shifting gears to FXR now. So 297, our follow-on FXR agonist, You know, we spent a lot of time trying to optimize whatever characteristics of the molecule we could, you know, obviously looking at potency and seal activity and other kinds of things. What surprised us, as you know, with 305 in the Argonne study was that the doses that we used, we saw more pritis than we would have expected, you know, from 305. All the information we saw in Phase 1. And so for us, thinking about how to use 305 in a way that gives better tolerability going forward is the path that we're thinking about for 305.

31:57 But 297 then, it became clear that Paritis, perhaps more so than lipids, is the thing we needed to really try to figure out how to improve upon. The confounding part of that is that nobody really understands what's causing paritis with these various FXRs that have seen it. Is it on target? Is it off target? Is it on target in certain tissues but not others. And so absent having the, you know, sort of confirmed mechanistic understanding of how to reduce pruritus, what we did was took other approaches that we could do sort of independent of knowing the mechanism. So number one is drill down the potency Two, as good a potency as you could possibly do. So we worked and worked and worked on that.

33:06 We put the data out at J.P. Morgan initially, and we'll have more at Easel.

33:11 But it's a very, very potent

33:15 FXR. It's the most potent one based on the data that we've generated side by side versus any other FXR agonist that's in development today. So number one, That's good because you will reduce the amount of drug that it takes to deliver the punch. So we know that FXR receptors are in the intestine and also in the liver in terms of the sites of efficacy for a compound that we would be looking for in NASH. And so in addition to Making these exquisitely potent for FXR and hopefully less potent for something else that we might not know, we aimed it directly at liver and intestine and not at plasma and skin because obviously if you have high plasma levels, you're going to be circulating the drug around to all kinds of other tissues in the body.

34:25 and we specifically thought it would be interesting to minimize the skin exposure of the drug as well. So it's really the twofold combination of having very, very good potency so that we'll be dosing just very small amounts of drug and then having that drug go directly to the sites where we need the drug and hopefully not at the sites where we don't need the drug, where only other things could happen. So that's our thesis. And, you know, there's a scenario where it might not play out as we hoped, but that sort of narrow scenario of bad luck, I guess, would be if it's FXR mediated, And if it's FXR mediated by FXR receptors inside the liver or intestine, then we may only have achieved a super, super potent version of 305 or some of the other, you know, FXRs that are out there today.

35:39 But if it's any other scenario, we have the chance to, you know, to come up with benefits. And that's what we'll be exploring. We think we can learn actually a fair amount in phase one. And we're on track to start that phase one study in the middle of this year with the data coming in in the first half of next year. It's a pretty straightforward plan. It looks like an excellent molecule. Again, we'll profile it more at easel. But, you know, it's a polished entrant into the field. Thank you. You're welcome.

36:26 Your next question is from Brian Scorney with Baird.

36:30 Hey, good afternoon, everyone. Thanks for taking the questions. I guess first, just on EDP 514, can you just walk us through how to think about the dosing here and where you want to target? Maximize Antiviral Activity. If I look at the results you have in the chimeric liver mouse model, it seems like dose escalation isn't really topping out despite going to pretty high mg per kg doses. Any thought on how to think about translating that data into a target dose in patients?

36:57 Yeah, I wouldn't translate the rodent model numbers into humans. What I wouldn't look at in that experiment is Thank you very much. I wouldn't spend too much time thinking about that translation. And, again, we'll get into the whole dose escalation work that we did at EASL when we lay the whole data set out, and you'll be able to take a good look at it then.

37:55 Great.

37:56 And then just if I could ask a question on the patient flow in the RSVP study. Can you just remind us how screening works here? Are you screening? Just first, primarily screening for patients with respiratory symptoms and then screening them in for RSV in the study. And do you have any data on, you know, how many patients come in with respiratory symptoms screen in for RSV versus screening out with influenza?

38:24 Yeah. So, you know, we take people, again, within 48 hours of symptoms. There's an in-office PCR that's done. We look for RSV versus flu A or flu B. And if you're positive for RSV and negative for flu A and negative for flu B, then you're a potential candidate. You know, obviously, I mean, there's more flu out there than there is RSV, so you're going to see More of that in these screens, but generally speaking, it's a straightforward test with a straightforward presentation of people coming in within 48 hours, which, again, we've seen many people coming in in that window.

39:22 I guess what I'm trying to get at is if eventually this moves into sort of a seasonal RSV treatment, I'm trying to just see if in the real world setting what sort of is a reasonable number to assume as a percent of flu, but then we could obviously kind of comp it to what like Tamiflu does and get a feel for the commercial opportunity.

39:44 Yeah, it changes every, you know, it doesn't correlate perfectly every year.

39:52 The seasonality is a little bit different and You know, what might be a more robust RSV season could be a lower flu season. So there is just this overarching seasonality to it. The patient numbers are probably, you know, not as high as flu. But again, I don't think people really fully know yet, in part, because this testing is not routinely done on a broad scale basis in clinical practice.

40:38 And in part because it's not that the tests don't exist, it's that the drugs don't exist, so people don't often order up the test. It's also different, too, to be thinking about the patient demographic that's in the RSVP study, which is the adult outpatient study, We know adults in general are a fraction of what they are. Adult RSV cases in general are a fraction of what they are in PEDs. So, you know, ultimately the question will drive down to, you know, what are those PED numbers? But they're, you know, they're very significant in PEDs. Again, every PED gets typically an RSV infection by the time They're age two or three.

41:27 It's just a question of severity, and it's a question of what happens once they get that infection.

41:36 Great. Thanks, Fred.

41:38 You're welcome. And ladies and gentlemen, as a reminder, 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 Patrick Truccio with Barenburg Capital Management.

41:56 Hi, this is Iris Ong for Patrick. Thanks for taking my question. So regarding EDP 938, can you tell us if you expect to evaluate the drug in elderly patients? And if so, would you move directly into a pivotal trial or would you anticipate running maybe another two phase two trials in this patient population? And then finally, would you anticipate having to run two pivotal trials for each patient population or is one pivotal trial sufficient? Thank you. Thank you for your question. I can address that. They are good questions. So I think for now we have informed that our next studies will be in the transplant and PIDS. We know that those populations are really unmet medical needs. We are not excluding for the next future to be looking into the elderly, obviously, as they are also a population of good target for RSVP.

42:55 But the plan for now would be to focus on the transplant and the pills. To your next question regarding pivotal studies, I think that's a very good question. Today, if you look at the guidance issued by FDA or EMA, I don't think there's a clear understanding of if we will need one or two pivotal studies like we usually do when we register a drug. I think it's going to be interesting to engage regulatory authorities as we are moving and progress our program. So we will know more as we obviously progress further.

43:35 Okay, got it. And then regarding RSVP, can you tell us what you would consider to be a highly successful top-line data result? Thanks. Well, I guess simply to make the primary and fourth with a nice p-value. I'd be happy to see that. And, you know, I think, you know, I think RGP is also an interesting study for us and maybe for the field, trying to understand the feasibility of how soon can you attract the patient with nasal samples that you can treat to prevent severity and progress to lower respiratory tract infections. And I think this is what we need to understand. And if we understand that we can put that in practice, I think, you know, that would be probably half of winning, you know, a cure for RSV if you have a good product.

44:31 Got it. Thank you. You're welcome. And there are no further questions at this time. I'll turn the call back over to Ms. Carol Maselli.

44:42 Thank you, everyone, for joining us today. If you have any further questions, feel free to give us a call in the office. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.