Enanta Pharmaceuticals Q1 2024 Earnings Call Transcript

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Provided by Quartr
February 7, 2024

There are 12 speakers on the call.

Operator

Good afternoon, and welcome to Enanta Pharmaceuticals Fiscal First Quarter Financial Results Conference Call. At this time, all participants are in a 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 would now like to turn the call over to Jennifer Vera, Investor Relations.

Operator

Please go ahead.

Speaker 1

Thank you, operator, and thanks to everyone for joining us this afternoon. The news release with our fiscal first quarter financial results was issued this afternoon and is available on our website. Making remarks on today's call are Doctor. Jay Luly, President and Chief Executive Officer and Paul Mellett, our Chief Financial Officer Doctor. Scott Roddinghouse, our Chief Medical Officer and Doctor.

Speaker 1

Tara Kiefer, Our Chief Product Strategy Officer will be available during the Q and A portion of this call. 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 ks and our other periodic reports filed with the SEC. Enanta does not undertake any obligation to update any forward looking statements made during this call. With that, I'd like to turn the call over to Doctor.

Speaker 1

Jay Luly, President and CEO. Jay?

Speaker 2

Thank you, Jennifer, and good afternoon, everyone. In the Q1 of 2024, Enanta began an important year, which has the potential to advance our programs in both virology and immunology and drive value across the company. Through our recent expansion into immunology, our mission continues to center around the development of small molecule for indications of high unmet need and we are leveraging our drug discovery capabilities to bolster our pipeline for near and long term value creation. Today, I'll provide an overview of our progress during the Q1, beginning with our respiratory syncytial virus or RSV program And then segue into our new immunology program targeting chronic spontaneous urticaria or CSU. RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in infants, children and other high risk populations, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease or asthma.

Speaker 2

Despite the availability of vaccines and prophylactic monoclonal antibodies, The uptake has been low and breakthrough infections will still occur. The current rate for adult RSV vaccine adoption is estimated to be only 11% of the eligible population. Further, both strategies for pediatric prophylaxis, The maternal vaccine and monoclonal antibodies provide short term passive immunity for infants and only shift the infant's first infection to the next season. Because of this significant need for safe and effective treatments, our goal is to develop an oral best in class treatment for RSV Through our broad development program, which includes zelicaprevir, an N protein inhibitor formerly known as EDP-nine thirty eight and EDP-three twenty three, an L protein inhibitor, both have fast track designation from the FDA. Our conviction in our approach to RSV is rooted in the core mechanism of our molecules, replication inhibition.

Speaker 2

We believe both zelicapivir and EDP-three twenty three have robust potential as monotherapies, but we're also excited by the opportunity to combine them and potentially broaden the treatment window or addressable patient populations. Selicapavir, the only N protein inhibitor in Clinical development is currently being studied in 2 Phase 2 studies of high risk patient populations, RSVPeds and RSV HR. RSV PEDS is a randomized double blind placebo controlled study in hospitalized It is a 2 part study of approximately 90 patients. The objective of the first part is to evaluate zelicapivir's safety and pharmacokinetics in multiple ascending doses to select the optimal dose for each age group. In the second part, the objective is to evaluate zelicapivir's any viral activity at the selected optimal dose.

Speaker 2

Symptom scores will be assessed throughout the treatment duration. RSV PEDS was designed as a smaller study that would allow us to demonstrate a trend toward improved virology metrics for zelicapivir to also move forward expeditiously into registrational studies. RSV HR is a randomized double blind placebo controlled study in adults with RSV infection who are at high risk of complications, including the adults over 65 years of age or individuals with asthma, congestive heart failure or chronic obstructive pulmonary disease known as COPD. Approximately 180 patients will be treated with 800 milligrams of zelicapivir or placebo for 5 days evaluated over a 28 day period thereafter. RSV HR's primary endpoint is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the respiratory infection intensity and impact questionnaire or RIQ symptom score scale.

Speaker 2

We will also be evaluating multiple secondary endpoints, including other clinical efficacy measures and antiviral activity, as well as pharmacokinetics and safety. In RSV HR, we are primarily looking to see a clinically meaningful The goal of this proof of concept study in high risk patients with community acquired RSV is to obtain directional efficacy data that would give us the confidence to move into Phase 3 as efficiently as possible. Currently both RSVPEDS and RSV HR continue to enroll and we have taken necessary steps to set up the trials to achieve enrollment around the world as quickly as possible with each study having a global footprint spanning at least 15 countries. We have been pleased to see a more normal RSV season in North America. Based on current enrollment trends, we anticipate reporting top line data RSV PEDS in the Q3 of 2024.

Speaker 2

As for RSV HR, we will provide additional guidance as the RSV season continues. Also ongoing in our RSV portfolio is the Phase 2a challenge study of EDP-three twenty three, A highly potent L protein inhibitor in development as a once daily oral treatment for RSV. In this randomized double blind placebo controlled study, up to 114 adult subjects will be infected with RSV And then randomized 1 to 1 to 1 to receive once daily dosing of either 600 milligrams of EDP-three twenty three, 200 milligrams of 3/23 with a loading dose of 600 milligrams on the 1st day or placebo for 5 days. Primary and secondary outcome measures include safety, changes in viral load measurements and changes in symptoms from baseline. We advanced EDP-three twenty three into the challenge study based on positive Phase 1 results in which the drug demonstrated favorable safety, Tolerability and pharmacokinetics in healthy volunteers and we are on track to report data from the challenge study in the Q3 of 2024.

Speaker 2

Now I'll turn to our work in immunology where our pipeline expansion builds on our expertise in small molecule drug discovery and virology, a scientifically adjacent area. Our team is focusing on areas where there is a strong understanding of the underlying disease pathology, allowing us to target the root cause of the disease. Moreover, we are concentrating on indications with high unmet medical need and a clear clinical development path, including well defined populations and biomarkers available for early signs of efficacy. We believe that we are well positioned to pursue immunologic indications and are excited to advance our new program in chronic spontaneous urticaria or CSU, which is a severely debilitating chronic inflammatory skin disease. Clinical manifestations include hives, which is also called urticaria or angioedema, which is characterized by pronounced deep tissue swelling or both.

Speaker 2

Patients with CSU also experienced symptoms beyond the skin manifestations, including sleep disturbances, fatigue, irritability, anxiety and depression. The disease can be severely disabling, significantly impair quality of life and affect performance at work or school. CSU is typically a self limiting disorder persisting for 2 to 5 years, although some reports estimate that more than half of the patients suffer for more than 5 years. It may also recur after months or years of full remission. CSU is estimated to affect 0.5% to 1% of the global population at any given time And there is a substantial unmet need for an efficacious oral agent.

Speaker 2

The standard of care treatment for CSU is antihistamines. However, in approximately half the patients, symptom alleviation is not adequate. There's a substantial unmet need for an efficacious oral agent as only a minority of cases are treated with one indicated biologic. Given the high unmet need for CSU patients, the opportunity in urticaria is significant. Our goal is to develop a best in disease oral KIT inhibitor treatment to reduce the number of mast cells, which are the primary driver of the disease.

Speaker 2

As mast cells are implicated in multiple allergic diseases, We have the potential to study our KIT inhibitor in additional indications. This strategy is supported by anti KIT monoclonal demonstrating potential best in disease efficacy in a Phase 2 clinical trial in CSU. Our prototype inhibitor exhibits potent inhibition of KIT in binding and cellular functional assays and is highly selective for KIT versus other kinases. We've observed favorable in vitro and in vivo ADME properties in our prototype, including a low potential for off target tissue penetration, a long half life and low drug drug interaction potential. We plan to announce a development candidate for CSU this year.

Speaker 2

We are very excited about our pipeline growth in immunology are pursuing additional targets with plans to introduce a second immunology program this year. With that, I'd like conclude by highlighting our upcoming milestones. We look forward to reporting results from our Phase 2a challenge study of EDP-three twenty three in the Q3 of 2024. And assuming the season continues to be a normal RSV season in the Northern Hemisphere, We anticipate reporting data from the RSV peds Phase 2 study of zelicapivir in the Q3 of 2024. Further, we plan to identify a clinical candidate for our CSU program this year.

Speaker 2

And finally, we plan to announce a second immunology program in 2024. Now I'll turn the call over to Paul to discuss our financials. Paul? Thank you,

Speaker 3

Jay. I would like to remind everyone that Nanta reports on the September 30 fiscal year schedule. Today, we are reporting results for our fiscal Q1 ended December 31, 2023. For the quarter, total revenue was $18,000,000 and consisted of royalty revenue earned on AbbVie's global MAVERIT net product sales. This compares to total revenue of $23,600,000 for the same period in 2022.

Speaker 3

As a reminder, 54.5 percent of Enanta's ongoing royalties from AbbVie's net sales of MAVVRET that are included in our revenue are being paid over to OMERS, the royalty buyer in our April 2023 royalty sale transaction. For financial reporting purposes, the sale transaction was treated as debt with the upfront purchase payment to us of $200,000,000 recorded as a liability. As such, we continue to record 100 percent of the royalties earned as revenue and will then amortize the debt liability proportionately As 54.5 percent of the cash royalty payments are paid to OMERS, until a cap of 1.42 times, the purchase payment is met, After which point, 100 percent of the cash royalty payments will be retained by Enanta. Non cash interest Interest expense was $3,400,000 for the 3 months ended December 31, 2023. Moving on to our other expenses, The 3 months ended December 31, 2023, research and development expenses totaled $36,400,000 compared to $40,900,000 for the same period in 2022.

Speaker 3

The decrease was primarily due to a decrease in costs associated with our COVID-nineteen program, as we previously announced that our plans to pursue any future COVID-nineteen efforts

Speaker 4

would be

Speaker 3

in the context of a collaboration. General and administrative expense for the quarter was $16,500,000 compared to $12,700,000 for the same period in 2022. This increase was primarily due to an increase in stock compensation expense and an increase in legal expenses related to the company's patent infringement suit against Pfizer. Other income net totaled 900,000 Enanta recorded an income tax benefit of $600,000 for the 3 months ended December 31, 2023, For interest earned on a pending $28,000,000 federal income tax refund, compared to an income tax benefit of less than $100,000 for the 3 months ended December 31, 2022. Net loss for the 3 months ended December 31, 2023 was $33,400,000 or a loss of $1.58 per diluted common share compared to a net loss of $29,000,000 or a loss of $1.39 per diluted common share for the corresponding period in 2022.

Speaker 3

Enanta ended the quarter with approximately 337,000,000 cash and marketable securities. We expect that our current cash, cash equivalents and short term marketable securities as well as our ongoing retained portion of royalties will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs fiscal 2027. Further financial details are included in our press release and will be available in our report on Form 10 Q1 filed. I'd now like to turn the call back to the operator and open up the lines for questions. Operator?

Operator

And thank you. And our first question comes from Roy Buchanan from JMP. Your line is now open.

Speaker 5

Hey, thanks

Speaker 6

for taking the questions. I just had a few on belacapavir. First one on the RSVP readout, presumably in 3Q. I guess, Under the negative scenario where you don't see any virological effects, is it conceivable that you just wind down the program, stop RZ HR or would you see our C HR readout. And then in that same scenario and if the challenge trial for 3/23 is highly positive, Would you potentially look to immediately combine the 2 agents?

Speaker 6

And I have a follow-up. Thanks.

Speaker 2

Thanks, Roy. This is Jay. So starting with the challenge study, 3/23 is also on track for Q3. It's a very potent L inhibitors. As you know, I know you know a lot about the data.

Speaker 2

And Given the potency, given the PK, given the huge multiples we drive over the Protein adjusted EC90, we're very hopeful that it should show efficacy Comparable to selacapavir, the question of getting into combination studies right away It's an interesting one, but I think we'll probably be most interested in Fully characterizing single agent efficacy for both zelicapivir and 3/23 in real world and then contemplate combinations. Of course, in parallel, You could be scouting out some of the combinations and challenge studies, foreshadowing that, but I think we wouldn't want to slow down single agent characterization of 3/23. The peds study, again, we're on track for Q3. You're asking an interesting question if peds didn't show anything, what would you do with HR? In their different patient populations, I think you got to look at the facts and circumstances around any clinical trial result in one patient population done under one set of conditions and then make good judgments as to how it might or might not relate to a different clinical trial in a different patient population under a different set of circumstances.

Speaker 2

So we just need to look at data. So that's my thought on that.

Speaker 6

Okay, great. Presumably HR is not too far behind. Just a follow-up. I wondered for zelacapivir, if you can put a dollar value on the 2 markets, the peds and the HR, just In your view, what do you think is a rough dollar value? Thank you.

Speaker 2

Well, there are no established therapeutics in this market. So I think there's a great opportunity to build The first opportunity for an RSV treatment ever in each of those patient populations and yet other high risk Patient populations. I'm not going to be able to give you an exact dollar amount, but it's got to be a $1,000,000,000 market opportunity. It has a $1,000,000,000 on it, let's just say that. And peds directionally is probably the bigger piece of that.

Speaker 2

Although, I think there's more data and information on RSV and peds than there is in adults. And so, we're also not going to underestimate what that adult market could ultimately look like. Clearly, there's been a lot of interest in that space in promoting vaccine opportunities for elderly. And they're doing quite well in prophylaxis, even though only a small portion of the eligible patient population is getting vaccinated and everybody else, which is the overwhelming majority of people aren't getting vaccinated and would still be susceptible to infections. And even some of the vaccinated people could be getting breakthrough infections.

Speaker 2

So Give us more time to see how that market evolves a little bit, work up final It's on a potential product profile. But we're very encouraged by Our position in the field, the sort of the leadership position we have in RSV portfolio, and also the fact that there are no approved drugs in the market is each unmet need. So it's a good opportunity.

Speaker 6

Okay. Thank you.

Speaker 2

You're welcome.

Operator

And thank you. And our next question comes from Roanna Ruiz from Leerink. Your line is now open.

Speaker 7

Great. Afternoon, everyone. So a question on your CSU program. So Could you walk us through some of the elements that excited you about this indication over other similar immunology indications? And I was curious what additional optimization might you try to be working on to get to a final candidate that could be deemed like best in disease?

Speaker 7

I have a follow-up after that.

Speaker 2

Okay. Well, I'll Handle part of that question and then I'll let Tara Kiefer, heads up product strategy, talk about The other part. So with regards to the optimization, I think we showed some data at JP Morgan on a prototype molecule, which We think is far along in terms of our optimization profile. We're still making lots and lots of molecules continuing to tweak bits and pieces. But Obviously, among the things we're looking at is just really honing down potency, selectivity, making sure we've got good safety And of course, our old friend pharmacokinetics and hopefully once daily dosing, All of those kinds of things that we like to build into every one of our molecules.

Speaker 2

CSU is attractive And maybe I'm already answering some of the questions, but we're not certainly limiting ourselves To that, I think it happened to be the 1st program that we've announced in the area. But we're working on a few other things. We're piloting other programs, getting involved. So you can expect that there will be a broader footprint certainly as our slide deck anticipates in the field and we go about it in the way that we've done in a lot of our well, in pretty much all of our programs. We get the biology Figured out and sorted really important to do that, try to figure out chemical matter that we can get into, Make sure we've got strong commercial rationale in terms of competitive landscape, potential product profiles, we set all that stuff, start making molecules, get on the boards, start filing intellectual property.

Speaker 2

And we tend to do all of that before we really announce program. So suffice it to say that's ongoing in other areas and as the year rolls out, we'll come out with more. Does that answer your question?

Speaker 1

Yes, that helps. And I have

Speaker 7

a follow-up on RSVPs as well. So given the top line coming, What do you hope to see in terms of efficacy and safety results? And how might you use that data to inform a go or no go decision for advancing to

Speaker 2

Yes, maybe since I didn't give Tara the chance of the last question, I'll let her take this one.

Speaker 1

Sure. Yes.

Speaker 8

Sorry. So, Ruan, as you know, the RSVP study, first in P, so doing some dose ranging and then Looking at that optimal dose at virology for the primary endpoint in the second part of the study. We'll certainly look at other endpoints, clinical endpoints like symptoms. But with the size of the study, we'll primarily be looking at virology endpoint. And really what we're hoping to see is some directional data and numerical trends in the virology endpoints that give us the confidence to take this program forward into a larger, more robust Phase 3 program as we move forward.

Speaker 8

So that's really what we're looking to achieve in this kind of initial team study. Got it. Thanks.

Operator

And thank you. And one moment for our next question. And our next question comes from Akash Tewari from Jefferies. Your line is now open.

Speaker 8

Hi, this is Phoebe on for Akash. Thank you for taking our question. It doesn't seem like the Phase 2b RSVP study is powered to hit on symptoms or viral load reduction. So what would be a strong enough signal for you to move it into Phase 3? And then additionally, how are you thinking about the oral From desivir failure for Gilead, does that change strategic value for your protein inhibitor at all?

Speaker 8

Thank you.

Speaker 2

You want to just build on Yes,

Speaker 8

I can build on for the RSVP piece. We will again primarily be looking at virology and I think There's not a lot of benchmarks in this area that we could point to or compare to. There is one data set out of a company called ArcBio where in a Phase 3 trial they showed about a 0.6 log drop. And that did translate into an improvement, specifically significant improvement on symptoms. So that is the one sort of benchmark that we have.

Speaker 8

But again, numerical trends and directional data showing that zelotapavir is showing an improved trend in virology compared to placebo would give us the confidence to move forward into a Phase 3 study. Again, we'll look at symptoms. And as you said, it is a small study. And the likelihood of seeing something on that certainly in The significant way is probably not as high, but we'll look at that and see what we get.

Speaker 2

And the second part, I guess, is, relates to, oral remdesivir for COVID. I mean, I guess our initial reaction, I mean, we like everybody else just got that news late yesterday afternoon. I think it simplifies the COVID landscape, which is one of the things that I think Everybody who's involved in COVID, including us, everybody who's interested in COVID, whether it's strategic or the government, They're trying to figure out what the competitive landscape is or what the arsenal of drugs is going to be available for COVID patients. And it seems like there's One fewer now. So that's going to help clarify things.

Speaker 2

I guess, Shionogi is another one that's Due to turnover of card, pretty soon here, I guess there's a question about What's Pfizer doing with their follow on molecule? We haven't seen that they've advanced it, but so with a question mark there that We'll hopefully get sorted here in the nearer term. And then, we'll have a more complete view of what that competitive Looks like which is again important for anybody who would be making funding decisions going forward. Our plan, as we've stated a few times before, is to only pursue 235 in the context of a

Operator

And our next question comes from Eric Joseph from JPMorgan. Your line is now open.

Speaker 5

Thanks. Just a quick

Operator

Eric, I'm sorry, you're sounding a little low there.

Speaker 5

I'm sorry, can you hear me now?

Speaker 3

Yes, sir.

Speaker 2

Yes. Okay.

Speaker 5

Thanks for taking the question. Just your 3Q guidance for reading out RSVP, Does that anticipate full accrual of your target of 90 patients? If you sort of And tracking under that goal after this season, do you go ahead with the readout or do you perhaps sort of push out timelines a bit?

Speaker 2

I think we're still targeting to at least hit the target enrollment. That's the plan. That's plan A and the report date on the full set in Q3.

Speaker 5

Okay, great. And sorry if I missed it earlier, but can you just comment a little bit Just how accrual is taking place with RSV high risk And sort of how much further behind it might be from full accrual or how much further behind basically readout from that study is tracking to RSVPs? Thank you.

Speaker 2

Yes. So, quarter after quarter, I've been asked, Which study do you think is going to read out? And I could never answer the question because Especially when we targeted a goal of Q3 for data, but as I Seth, I think at the JPMorgan conference, as we get a little further into the season, we'll have better sense of it and should be able to make A call and clearly today we're making that call. It looks like Pete's is the one that will. In terms of the HR, how far behind is that I think we just got to continue the recruitment in that.

Speaker 2

Obviously, I think we're going to need to go to the Southern Hemisphere, continue on beyond the Northern Hemisphere season And we'll just give updates as we go. Once we have a good More crisp target guidance to provide if we will. But we did see And to remind you, it's a larger study than peds, right? And so it's roughly twice the size we can and it We did see a nice uptick in this Northern Hemisphere season. It was really gratifying to see that.

Speaker 2

So we've got over 100 sites now. We're in over 15 countries. We've got a pretty big catcher smed on now and it's just all about execution And hoping that the trends towards normalcy continue. But That's been again something that we've seen this COVID season in terms of when it started and the shape of the season and everything else. This is the 1st season we've seen like this in years.

Speaker 5

Okay, great. That's helpful. Maybe one follow-up if I could. If you have a clear what needs to be clear evidence of reducing viral load in RSVPs, Can you talk a little bit about gating steps to running an efficacy study in the pediatric population? Is that dependent on results from RSV high risk?

Speaker 5

Thank you.

Speaker 2

No, I mean, I can let Scott comment on that, but They're just very different patient population. Scott, I don't know if you

Speaker 9

Yes. Sorry, Scott Roddinghouse. It's different patient populations And we'd feel comfortable moving forward in pediatrics with positive results from our pediatric study.

Speaker 5

Okay, great. Thanks for taking the questions.

Speaker 2

You're welcome.

Operator

And thank you. And one moment for our next question. And our next question is Jay Olson from OpCo. Your line is now open.

Speaker 10

Hi, this is Chung on the line for Jay. Thanks for taking the question and congrats on progress. Maybe two questions from us. First on the RSV program. Just for dadecaprevir, if you decided to move the program into a pivotal study.

Speaker 10

Just wondering how are you thinking about the adoption of RSV vaccine in your target patient population. And would you maybe exclude patients who recently took the vaccine? What are some other thoughts around that for the moment? And I have another question for the CSU program.

Speaker 2

Pat, Scott, you want to take the RSV?

Speaker 9

Yes, for sure. So from a vaccine perspective, Obviously, the coverage of vaccines is going to be far from 100% and they're not 100% efficacious. So, we still see the market and the clinical opportunity persisting there. So that's the first important point. And then in terms of a putative Phase 3 study in pediatrics, we envision including patients broadly, including patients who break through on vaccine or nirsevimab.

Speaker 9

So We, again, envision broadly studying patients in pediatrics.

Speaker 10

That's helpful. And for the CSCU program, I'm just wondering your thoughts on how would you position the oral inhibitor into the treatment landscape for CSU and there's like recent BDK inhibitor read out positively. So just wondering if you think that's kind of a good benchmark for efficacy you're shooting for? Thanks.

Speaker 8

Hi, this is Tara. So, yes, thanks for the question. I guess the way we look at the CSU landscape is, broadly at all the different mechanisms. If you think about the standard of care being antihistamines and only 50% of the patients really being controlled on that, Very few of those go on to get the only indicated biologic, which is Xolair. The data coming through from the BTK inhibitors, which are an oral option in development.

Speaker 8

Those studies did read out positive. I would kind of put their efficacy to be somewhat similar to Xolair in that camp. What we're excited about From a KIT inhibitor perspective is the data that was generated through an antibody program in Phase 2 where They have seen some of the best efficacy in this disease so far. And that's really the benchmark we're looking towards and hoping to replicate that data with an oral options. So that's sort of how we're seeing this evolve.

Speaker 8

Obviously, we'll continue to as the data comes out, hoping to provide additional efficacy over and above what BTK inhibitor might provide.

Speaker 10

Yes, that's maybe a quick follow-up on the last part. I think there are some like side effects for antibody approach, maybe including the Color change or some change in blood cells. So do you think the oral, K inhibitor may have some advantages on safety as well? Thanks.

Speaker 8

Yes. So there are certainly known side effects on target side effects for KIT inhibitors. Overall, the antibody has had a good safety profile. Most of the AEs were mild or moderate and they resolved. The ones that are known on target that you mentioned in terms of neutropenia, There were generally mild hematologic impacts and the neutropenia has sort of stabilized after a short time period of week or 2 of dosing.

Speaker 8

And so what we did find out is it didn't get worse with longer dosing. And so it seems quite manageable, at least at the levels that they're observing so far in the clinic. They were not associated with infections, at least in the trials with Barzo. And so we're obviously keeping an eye on it, but we don't think that will be a limitation.

Speaker 10

Okay, got it. Thank you so much.

Operator

And our next question comes from Brian Skorney from Baird. Your line is now open.

Speaker 11

Taking the question. This is Charlie on for Brian. Just a couple of quick ones here. We were wondering if you could give us some more color on how severe symptoms are and how long RSV tends to last more thinking about pediatric and high risk patients relative both to each other and to low risk adults, such as those that were enrolled in the RSVP trial? And then secondly, just You spoke to antibodies and CSU.

Speaker 11

Just wondering, is this a main focus for you guys in terms of how you're designing the specificity of your lead candidates and do you consider that a bar for you to reach and how else are you thinking about that? Thank you.

Speaker 9

So I'll jump in on the RSV question. The kids that we've been enrolling are typical kids often with their first episode of RSV infection and they have symptoms typically pushing 2 weeks longer than you'd expect to see in young healthy adults given their immune naivete. So that's kind of the length of symptoms, 10 to 14 days. And again, severity varies In our study, the sorts of symptoms that can often get you hospitalized, so fairly severe. And with adults, Again, the high risk adults that we're enrolling in our study, patients with COPD, CHF, again have a more severe symptomatic profile again, a couple of weeks in most cases.

Speaker 9

So that's I think the general severity and length of that disease, if that helps.

Speaker 2

I'm sorry, could you repeat your question on CSU?

Speaker 11

Yes. And That's very helpful. Thank you. On RSV, but for CSU, we were just wondering how you're thinking about designing the specificity and thinking about the antibody that you mentioned earlier, is that kind of your goal in terms of the specificity of your molecules?

Speaker 8

Yes. So I mean, the goal of the program is to have something that's potent to kit. And so we've looked at that clinically in both binding and cellular function assays and we see nanomolar activity there and then to be highly selective against KIT versus other kinases. We shared some preliminary data for that a few weeks ago and showing good selectivity. We continue to optimize the compounds that we have and study them for selectivity, but that is the goal.

Speaker 8

Yes.

Speaker 10

Thank you. You bet.

Operator

And thank And our next question comes from Ed Arce from H. C. Wainwright. Your line is now open.

Speaker 4

Hi, everyone. Thank you for taking my questions. This is Thomas Yip asking a couple of questions for Ed. So for the new immunology program that is to be can be related this year, Just trying to figure out what are some expectations that you have for now, would it be for a large disease or small disease or something along the line of the new inhibitor program in terms of large market And then lastly, a large unmet need as well.

Speaker 8

Yes. So we're primarily targeting

Speaker 2

I'm sorry, were you talking about a future To be announced program? Yes, the second

Speaker 4

immunologic program test to be announced Yes.

Speaker 2

So we yes, I mean, we're trying to be very thoughtful about it going after Good markets, right? Good market scenarios where we think a small molecule could make an important impact. But beyond that, we'll announce We'll announce the program when we announce it.

Speaker 8

I mean, I think some of the things we think about in selecting programs, obviously having a good market opportunity, Something that has a high unmet medical need, ideally programs where there's a clear clinical path and Biomarkers or early signs of efficacy that we can get early on in the program, and really understanding the Kind of underlying disease cause of the disease and having confidence in the target and mechanism are some of the criteria we look at.

Speaker 4

Got it. Thank you for the additional color. And then this question, one financial question perhaps for Paul. Just trying to confirm Last quarter for fiscal year 2024 OpEx guidance, RMB 100,000,000 to 120,000,000 and then G and A 45,000,000 to 50, Just trying to figure out whether that's still on target for this fiscal year?

Speaker 3

Yes, that is still our targeted spend at this point, yes.

Speaker 4

All right. Fantastic. Thank you again for taking our questions.

Speaker 1

Thank you.

Operator

And thank you. And I am showing no further questions. I would now like to turn the call back over to Jennifer Vera for closing remarks.

Speaker 1

Thank you everyone for joining us today. If you have additional questions, please feel free to contact us either by e mail or call the office. Thanks so much and have a good night.

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Enanta Pharmaceuticals Q1 2024
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