Enanta Pharmaceuticals Q2 2024 Earnings Call Transcript

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Provided by Quartr
May 6, 2024

There are 13 speakers on the call.

Operator

Good afternoon, and welcome to Enanta Pharmaceuticals Fiscal Second 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 Q2 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 the call. Before we begin with our formal remarks, we want to remind you that we will be making forward looking statements. These statements may include our plans and expectations with respect to our research and development pipeline and financial projections. All of these statements involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from the statements. A description of these risks is in our most recent Form 10 ks and other periodic reports filed with the SEC.

Speaker 1

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 Doctor. Jay Luly, President and CEO. Jay?

Speaker 2

Thank you, Jennifer, and good afternoon, everyone. Throughout 2024, Ananta has remained squarely focused on advancing our virology and immunology pipeline to bring important oral therapeutics to market. Our commitment to developing treatments for areas of high unmet need is driven by our mission to transform patients' lives with curative therapies. And we are determined to achieve our milestones to drive near and long term shareholder value to fulfill this mission. Our focus is critical as we approach meaningful inflection points with the potential to develop the first antiviral treatment for RSV.

Speaker 2

With that, today I'll begin with an overview of our programs beginning with our respiratory syncytial virus or RSV programs and then discuss our immunology program for chronic spontaneous urticaria or CSU. As a reminder, RSV is the 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, asthma or other high risk conditions. Despite the availability of prophylactic options such as vaccines and monoclonal antibodies, there's a clear need for a safe and effective oral RSV antiviral treatment. Adoption of vaccines has been suboptimal and breakthrough infections still occur. Additionally, pediatric monoclonal antibodies only provide passive immunity for a few months and not long term protection against the infection.

Speaker 2

With this clear need, we have developed a broad clinical program that has the potential to enable multiple opportunities to treat RSV. The RSV pipeline includes the most advanced clinical replication inhibitors, zelicapivir, formerly known as EDP-nine thirty eight, an N protein inhibitor, as well as EDP-three twenty three, an L protein inhibitor. Zillicapavir is currently being studied in high risk patient populations in 2 Phase 2 studies RSVPeds and RSV HR. RSVPEDS is a first in pediatrics Phase 2 randomized double blind placebo controlled study in hospitalized and non hospitalized RSV patients aged 28 days to 36 months. The study which will enroll approximately 90 patients is being conducted in 2 parts.

Speaker 2

As this is the first in pediatric study, the objective of the first part is to evaluate the safety and pharmacokinetics of zelicapivir in multiple ascending doses to select the optimal dose for each age group. The second part of the study will evaluate the antiviral activity of zelicapavir at the selected dose and virology and symptom scores will be assessed throughout the treatment duration. This study was designed as a small proof of concept in pediatric patients to show a trend toward improved virology metrics for zelicapivir compared to placebo and to give confidence to move forward efficiently into larger registrational studies. The key objective of this study is to show improvement in virology endpoints in patients on zilacapavir compared to placebo sufficient to allow us to advance into Phase 3. Currently, we have partially enrolled the last age cohort of 20 patients in Part 2 of the study.

Speaker 2

As this cohort can only enroll patients 28 days to 6 months of age, the eligible population is narrower and we will need to continue to recruit in the Southern Hemisphere. As we monitor the RSV season in the Southern Hemisphere, anticipate reporting data from this study in the second half of twenty twenty four. RSV HR is a Phase 2 randomized double blind placebo controlled study of approximately 180 adults with RSV infection who are at high risk of complications, including the elderly, those with congestive heart failure, chronic obstructive pulmonary disease or asthma. The primary endpoint for RSV HR is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the respiratory infection intensity and impact questionnaire symptom scale. Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics and safety of zelicapivir.

Speaker 2

The primary objective of this study is to show an improvement in time to symptom resolution. Given the study was designed to be a small Phase 2 proof of concept study, it is powered based on a 50% reduction in symptom resolution. However, as there are no data showing a statistically significant effect on symptoms in community acquired RSV adult population with which to benchmark, this reduction likely represents a high bar. Therefore, directional efficacy data that is clinically meaningful would provide us with conviction to move directly into Phase 3. Enrollment is progressing and we will provide additional guidance on the RSV HR study as the Southern Hemisphere RSV season evolves.

Speaker 2

Also ongoing in our RSV portfolio is the Phase 2a challenge study of EDP-three 23, which is in development as a once daily oral treatment for RSV. In this randomized double blind placebo controlled study up to 114 healthy 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 EDP-three 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. The development of EDP-three twenty three is supported by positive Phase 1 results in which the drug demonstrated favorable safety, tolerability and pharmacokinetics in healthy volunteers. We anticipate reporting data from this challenge study in the Q3 of 2024.

Speaker 2

We believe either zelicapavir or EDP-three twenty three would be effective as a monotherapy because they do not have cross resistance, we could also potentially use them in combination to broaden the treatment window or expand the eligible patient population to harder to treat patients. Also in respiratory virology, data from SPRINT, our Phase 2 study of EDP-two thirty five, a 3CL protease inhibitor, was presented in April at the ECCMID Conference, formerly known as ECCMID. We are pleased to present this comprehensive data package in a scientific forum for the first time. As a reminder, we will conduct any future COVID-nineteen work in the context of a collaboration. I'll now turn to our work in immunology where we are concentrating on indications with a high unmet medical need and a clear clinical development path, including well defined populations and biomarkers available for early signs of efficacy.

Speaker 2

Our first immunology indication is CSU, a severely debilitating chronic inflammatory skin disease, which can continue for years before remission. Clinical manifestations include urticaria, commonly called hives, as well as angioedema, which is characterized by pronounced deep tissue swelling. The disease can be severely disabling, significantly impair quality of life and affect performance at work or school as patients with CSU can experience symptoms beyond the skin manifestations, including sleep disturbances, fatigue, irritability, anxiety and depression. CSU is estimated to affect 0.5% to 1% of the global population at any given time. The standard of care for CSU is anyhistamines, but in approximately half patients symptoms are not alleviated and a minority of patients are treated with one indicated biologic.

Speaker 2

Consequently, there is a substantial unmet need for a new efficacious drug that can be conveniently dosed as an oral agent. Mast cells are the primary driver for disease in CSU as well as being involved in multiple other allergic diseases. In our first immunology program, we are seeking to develop a vestin disease oral KIT inhibitor treatment that reduces the number of mast cells available to drive pathology in patients suffering from CSU. We are also encouraged by the potential to study KIT inhibition in additional indications. Currently, our prototype KIT inhibitors and pre clinical development demonstrate potent inhibition and are highly selective for KIT.

Speaker 2

We continue to optimize these leads around potency, selectivity and DMPK properties and we are on track to select a development candidate in the Q4 of 2020 4 and plan to move into the clinic shortly thereafter. We are excited about our pipeline growth into immunology and team's ability to translate the learnings from our previous success with small molecule drugs to enable our development of a best in disease therapeutic for CSU. We are also pursuing additional immunology targets and look forward to introducing a second program this year. Beyond our pipeline, I would also like to take a moment to welcome Matthew Kowalski as our Chief Legal Officer, who joined last week. Matt is a strong addition to our team as he brings more than 20 years of experience in the life sciences industry handling corporate governance, public company reporting, intellectual property, financing, business development and M and A activities.

Speaker 2

At Ananta, he will lead all legal and compliance activities for the company and provide strategic guidance and corporate governance oversight. With that, I'd like to conclude by highlighting our upcoming milestones. We anticipate reporting data from the Phase 2a challenge study of EDP-three twenty three in the Q3 and reporting data from the Phase 2 pediatric study of zelicapavir in the second half of this year. Further, we plan to identify a clinical candidate for our CSU program in the Q4. And finally, we also plan to announce

Speaker 3

I would like to remind everyone that Ananta reports on a September 30 fiscal year schedule. Today, we are reporting results for our fiscal 2nd quarter ended March 31, 2024. For the quarter, total revenue was $17,100,000 and consisted of royalty revenue earned on AbbVie's global maverick net product sales. This compares to total revenue of $17,800,000 for the same period in 2023. As a reminder, our royalties are calculated on a calendar year basis.

Speaker 3

Therefore, royalties for our fiscal Q1 ending December 31 were calculated at 12%, the highest royalty rate for the year and royalties for our fiscal quarter ending March 31 are calculated at 10%, our lowest royalty tier. Of note, 54.5 percent of Ananda's ongoing royalties from AbbVie's net sales of MAVERICK that are included in our revenue are being paid 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 reported as a liability. As such, we continue to record 100 percent of the royalties earned as revenue and will then amortize the debt liability at 54.5 percent of the cash royalty payments are paid to OMERS through June 30, 2,032, subject to a cap of 1.42 times the purchase payment after which point 100 percent of the cash royalty payments will be retained by Enanta. Interest expense for the debt will be recorded in Enanta's consolidated statement of operations based on an imputed interest rate.

Speaker 3

Interest expense was $2,600,000 for the 3 months ended March 31, 2024. Moving on to other expenses. For the 3 months ended March 31, 2024, research and development expenses totaled $35,600,000 compared to $43,500,000 for the same period in 2023. The decrease was primarily due to a decrease in costs associated with our COVID-nineteen program as we previously announced that plans to pursue any future COVID-nineteen efforts would be in the context of a collaboration. This was partially offset by increased costs associated with our RSV program and our recently announced immunology programs.

Speaker 3

General and administrative expense for the quarter was $14,200,000 compared to $13,800,000 for the same period in 2023. This increase was primarily due to an increase in legal expenses related to our patent infringement lawsuit against Pfizer. Enanta recorded an income tax benefit of $400,000 for the 3 months ended March 31, 2024 for interest earned in a pending $28,000,000 federal income tax refund compared to an income tax expense of less than $100,000 for the 3 months ended March 31, 2023. Net loss for the 3 months ended March 31, 2024 was $31,200,000 or a loss of $1.47 per diluted common share compared to a net loss of $37,700,000 or a loss of $1.79 per diluted common share for the corresponding period in 2023. At this fiscal year midpoint, we are updating our expense guidance.

Speaker 3

We now expect our research and development expense to be between $125,000,000 $145,000,000 and our general and administrative expense to be between $50,000,000 60,000,000 dollars The research and development expense increase reflects the impact of our new immunology program as well as additional efforts to accelerate our RSV clinical studies. The general and administrative expense increase is due to additional stock compensation expense and costs associated with pursuing our patent infringement lawsuit. Enanta ended the quarter with approximately $300,000,000 cash and marketable securities. We expect that our current cash, cash equivalents and short term marketable securities as well as our retained portion of ongoing royalties will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs through the Q3 of fiscal 2027. Further financial details are included in our press release and will be available in our report on Form 10 Q when filed.

Speaker 3

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 Akash Tewari from Jefferies. Your line is now open.

Speaker 4

Hi, this is Kathy on for Akash. So I had a question for RCPs. Since RCPs isn't explicitly powered to hit on viral loads or symptoms, what will you be looking at in terms of the data to inform your design for Phase 3? And as such, how should we think about gauging efficacy or safety? And then how much of a read across do you believe the data will have for our CHR?

Speaker 4

And then are you expecting a symptom benefit of like 1 or 2 days? Thank you.

Speaker 2

Thanks for the question. This is Jay. I think I'll hand it over to Tara Kiefer to talk about how we were going to be viewing the data set coming out of peds. Tara?

Speaker 5

Sure. Yes. So the RCPED study is our proof of concept Phase 2 study in pediatrics. So we have to think about it a little bit differently than our adult study in Phase II because this is the first time that we're dosing children in this young age range of 28 days to 3 years. So we have to first confirm the safety profile and the dose.

Speaker 5

And so the study has been done in 2 parts. Part 1, the primary endpoint is safety and PK and done in a dose dose ascending fashion and we select the optimal dose from that part, which has been studied in Part 2. And in that part, the primary objective is to look at the virology endpoint. So we're primarily again looking for improvement in virology endpoints between the patients on 938 or zelcaprevir and placebo with directional data that would give us the confidence to move into a Phase 3 study. So we'll look at a number of different virology endpoints.

Speaker 5

We'll also look at the clinical endpoints as well. But primarily, we'll be looking at virology. It's hard to give a specific threshold or a bar in terms of what we're looking at, because there's not a lot of data out there in RSV for naturally acquired RSV in children. But there's one study that we can point to from a company called ArcBio that did a Phase 3 study in pediatrics in China. And they did show a 0.6 log drop at day 4, a statistically significant effect in virology.

Speaker 5

And they also in that same study demonstrated an improvement in symptoms. So we're not able to really give any kind of a bar that we're looking for, but we're really interested in the totality of the data and showing those trends and directional data that would give us the confidence to move into a larger, more well powered study to able to tease out these effects.

Operator

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

Speaker 6

Great. Thank you. Just a couple of questions related to the immunology program, I guess for this kits development candidate. Can you talk a little bit about your strategic plans with respect to clinical development there? I guess, to the extent you might be seeking a strategic partner at some point along the way, Is there a certain sort of hurdles kind of milestones you'd want to see cleared first?

Speaker 6

And then secondly, just noting that you're looking to expand into or expand with the second immunology program. Can you give us a bit of a preview there in terms of either target you might be pursuing? Are you perhaps doubling down on KIT? Thanks very much.

Speaker 2

Thanks, Eric. This is Jay. So we're working up a few different approaches in parallel to figure out which we might prioritize going forward. So it's a little early to be discussing that. I think you asked where we doubling down on kit.

Speaker 2

We have one major kit program now. I think we're looking to broaden beyond that. And so we'll provide more detail as the year progresses and after we've generated more data in house, made more molecules in house, filed intellectual property and so forth. So stay tuned on that front. With regards to I wasn't quite sure on your the first part of your question, you were talking about strategic partnering.

Speaker 2

I mean, our plan just in a nutshell initially at least is to again identify the candidate in the Q4. We're going to be aiming to get it into the clinic hopefully rapidly thereafter. And then Phase 1, I think should be fairly straightforward and healthy. The nice thing is with this mechanism you can get sort of surrogate readouts of target engagement by looking at tryptase changes. So that will help a lot having the biomarker available to us.

Speaker 2

And then the clinical development in CSU I think is actually pretty straightforward. So we would be thinking about progressing to a fairly straightforward proof of concept study. It's a defined accessible and large patient population. So we hopefully won't have the seasonal trends that we experience in RSV and are looking very much forward to progressing that first program in immunology and then again bringing on additional targets and mechanisms as time goes on.

Speaker 5

Can I just add one thing to that Jay is the biomarker that Jay mentioned we can monitor in Phase 1 in healthy volunteers is serum triptase? There's a lot of data out there generated from some of the monoclonal antibodies against kits from CellDex that have nicely been able to show a tight correlation with impacts on that biomarker and ultimate clinical outcomes. So I think it's something that really can derisk the program early on in those Phase 1 studies.

Speaker 6

That's great. Thanks for taking the questions.

Speaker 7

You're welcome.

Operator

And thank you. And one moment for our next question. And our next question comes from Ed Arce from H. C. Wainwright.

Operator

Your line is now open.

Speaker 7

Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So first, can you outline what's your estimate of the patient population breakdown between the Northern and Southern Hemisphere to date, both for the RCP study and also for the HR study as well?

Speaker 2

Are you making reference to numbers of sites? You say patient population, but are you talking about markets? Are you talking about clinical trial conduct?

Speaker 7

More on the clinical trial conduct, so perhaps the number of sites so both the number of sites or the number of patients enrolled, just a ballpark sandwich?

Speaker 2

Yes. I don't have the exact figures in front of me. We have I mean, maybe Scott, maybe I'll just let you amplify on that.

Speaker 8

Yes. Sure. Thanks, Jay. So we've enrolled patients in both Northern and Southern Hemispheres in both the pediatric and the high risk studies, including in the current season ongoing in the South. So I don't have the exact numbers in front of me either, but we are continuing to enroll actively in both of those studies.

Speaker 8

And as Jay mentioned on the call, in the pediatric study, in particular, we're down to the last cohort and enrolling in the South.

Speaker 2

Yes. I but I think directionally maybe your question the Northern Hemisphere beyond question is more highly represented in terms of clinical trial sites than the Southern Hemisphere. I mean, we're in many different European countries, many different North American countries. We're in Asia. In the Southern Hemisphere, we're in South Africa, we're in Brazil, we're in Argentina, New Zealand, Australia, not as larger footprint in the Southern Hemisphere, but nonetheless, we're hoping to make good progress on enrollment in that and wrap this up as soon as possible.

Speaker 7

Understood. And then just a follow-up on that. Can you remind us how much overlap are there between the 7 Hemisphere RSV season and flu season? And also do you expect to that point for the HLR study, do you expect the study to complete enrollment kind of in line with the conclusion of the 7 hemisphere out of space season?

Speaker 2

Did you was the first question about overlap with the flu season?

Speaker 7

Yes. How much overlap are there between the RHB OSP season and the flu season?

Speaker 2

I mean, generally, they're somewhat correlated, but even in any given year, they can deviate a little bit one way or the other. Flu could come on a little earlier or a little later, come on twice. RSV has been and flu, but especially RSV have been substantially impacted by the pandemic years in terms of just only more recently starting to settle down into what we would call more normal seasonality. So I think again, we follow we track the CR species and much more closely than flu. As it relates to HR, my guess is we'll need to come back to the Northern Hemisphere, given that we again have just much stronger footprint there.

Speaker 2

We made excellent strides in the Northern Hemisphere this year. That's why especially in the United States, it was a very nice season for us. So we may need some of that as well. Again, we'll be tracking this and reporting progress later this summer when we're well into the Southern Hemisphere season and we'll be able to forecast a little bit better based on more current data. But that's my expectation.

Speaker 7

Okay, understood. Thank you again for taking my questions and we look forward to the progress in the second half of this year.

Speaker 2

Thank you. You're welcome.

Operator

And thank you. And one moment for our next question. And our next question comes from Roy Buchanan from Citizens JMP. Your line is now open.

Speaker 9

Hey, thanks for taking the question. Just a couple on RSV. Jay, for the RSV HR, I think I heard you say that it was powered for a 50% reduction in symptoms and it's probably a high bar. Just wondering where that, I guess, conclusion about it being a high bar comes from. I think the challenge trial you had a 75% reduction in symptoms.

Speaker 9

And are you just interpolating between that and RSVP? Or is there something you're seeing in the trial?

Speaker 2

Yes. So to be clear, we're talking about time to resolution of symptoms. So it's different than in the challenge. We're looking at the number of days improvement in time to resolution of symptoms versus placebo. I mean, I can give a little color on that.

Speaker 2

I think, for example, with flu and a placebo study, Entera can correct me if I'm wrong, NusaVad, a 4 day, time period for time to resolution and Tamiflu will shorten that by a day. So it's a 3 day time resolution. So it's a one day shortening out of 4 days, that's a 25% improvement in time to resolution. And so the way this was powered with HR and in order to keep it a relatively small study of only just under 200 patients, it was powered on a 50% effect. Had we powered it on a 25% effect that the study would be even much larger.

Speaker 2

So it's that fine balance of running a Phase 2 study that is enabling of a pivotal trial, keeping it at a manageable size. And we felt with a couple of 100 patients, even though it's a high bar to reach stat 7 on the way it was powered, we should be able to make good decisions based on clinically meaningful improvements. And again, shortening time to resolution of symptoms by 1 or more days would be clinically meaningful.

Speaker 9

Okay. Makes sense. And then for the 3/23 challenge, what are you hoping to see there? We've said many times that zelicapivir data is probably best in class. Are you expecting to see something similar?

Speaker 9

Do you need to see something similar? Just help us think about that. Thanks.

Speaker 2

Yes. Selicapivir does set a high bar. The mechanism is an in protein inhibitor. It is about the best challenge study data in any book companies ever put on the boards. So it does represent a high bar.

Speaker 2

That said, 323 is another mechanism. It's a polymerase inhibitor. It's a pikamolar polymerase inhibitor. So it's super potent. Can we replicate the same best in class data that we saw with zilacapavir?

Speaker 2

We'll see. Hopefully, yes. It's hard to do much better. I think we want to be in the same range to declare it as a strong player in the field. But based on every bit of data that we have pre clinically and our Phase 1 data, which showed good safety, tolerability, wonderful exposures after QD dosing and again very, very strong virology, we've set it up about as best as we can.

Speaker 2

We're running it at the same clinical site as we ran the zillicapivir trial. So we'll see. So we should have data for that in Q3 next quarter.

Speaker 9

Okay. Thank you.

Speaker 2

You're welcome.

Operator

And thank you. And one moment for our next question. And our next question comes from Ruano Ruiz from Leerink Partners. Your line is now open.

Speaker 10

Hey, this is Nick Gassik on for Roan. Thanks for taking our questions. Maybe first on RSV, could you give us a sense of how close you are to completing enrollment at a younger age cohort of RSV peds? Maybe how long do you think it could take to analyze and ultimately share the data afterwards?

Speaker 2

Yes. Again, so there are 2 parts to the study. Part 1 is completed in all age cohorts. Part 2 of this study is done in the older age cohorts and we're down to the final cohort of 20 patients. It's the youngest children from age 28 days to 6 months.

Speaker 2

And we've been actively recruiting that cohort. So we're in the home stretch and we just unfortunately, we can our pool of patients is now only one 6th of what it was based on age groups. So it's a narrower pool than any older children, we really have to we can't enroll in the study anymore. So we're just really zeroed in focused on getting the remaining young children to fill out this cohort.

Speaker 10

Got it. Thanks, Jay. And then maybe on CSU, curious, what are you hoping to see in a future Phase 1 for your oral inhibitor in terms of safety? Maybe how should we think about frequency administration for this asset? Is it once daily, twice daily, how should we think about that?

Speaker 2

Well, we're still finalizing the candidate. Again, we were targeting to have the finalist in Q4. But suffice it to say, we're very much zeroed in on QD dosing. We've made molecules that are very potent, they're very selective. We're optimizing DMPK profiles, tissue distribution, a number of other sorts of parameters like that to make it the kind of candidate that we typically bring forward.

Speaker 2

So we've already shown data on a strong prototype and we continue to the chemists are very busy. Well, not just chemists, but the chemists and all the biology people who are doing the characterization and our DMPK and safety team are working very, very diligently on this. So we would be aiming for a QD candidate that would be have the best safety profile we can provide as well as has good potency and selectivity.

Speaker 10

That's helpful. Thank you.

Operator

You're welcome. And thank you. And one moment for our next question. And our next question comes from Brian Skorney from Baird. Your line is now open.

Speaker 8

Hi. This is Luke on for Brian. For EDP-three twenty three, can you remind us of your current thoughts on potentially entering a Phase 2b in otherwise healthy adults as opposed to starting with the high risk in pediatric populations like you've done with zelacapivir? And would you wait for RSVPs or RSVHR data to make this decision?

Speaker 2

Yes. That's a good question. I mean, the short answer is we won't do another RSV study in otherwise healthy adults. They just we found out from our RSVP trial that they're otherwise healthy folks just resolve the self resolve the infection so quickly on their own. So they're really not in need of a therapy.

Speaker 2

We would only focus on high risk patient populations. And we're hoping to have an abundance of data here in the second half. We'll have 3/23 data, we'll have PEDS data, we'll be able to look at the totality of the information and figure out how best to position 3 to 3. So for us, it's been about bringing another strong mechanism forward. We've been working on this from the beginning, I guess.

Speaker 2

We've been working on it for a few years now to bring forward another differentiated asset in RSV. And that could give us the potential for doing combination therapy down the road and particularly hard to treat patient populations. Potentially it could help widen the treatment window where we to go after a patient with 2 drugs rather than 1. So it's just part of our strategy overall to try to build a leadership position in RSV as a therapeutics company. And the more sort of cards we have to play, I think we can come up with ways to leverage another asset over time.

Speaker 2

So the key is getting it up to a strong threshold on the challenge study data first.

Speaker 8

Great. Thank you.

Operator

And thank you. And one moment for our next question. And our next question comes from Liza Bayko from EVR. Your line is now open.

Speaker 11

Hi. This is Seema on for Lisa.

Speaker 5

I have a

Speaker 11

question on the 3/23 program. What doses of 3/23 are you testing in Phase IIa human challenge study?

Speaker 2

Yes. So, we're looking at a couple of different dose, regimen. So the first is 600 milligrams straight across for 5 days. The other is 600 milligram loading dose on day 1 followed by 200 milligrams on each subsequent day. It's kind of like in antibiotics they do that sometimes they give you a loading dose on day 1 and then a lower maintenance dose for a few days thereafter.

Speaker 2

So we just put both of them in. And I think in theory either at least based on calculations and modeling either has a good chance of demonstrating the activity we want. 1 obviously is a lower dose and has different cost of goods ramifications, etcetera, etcetera. So we're just the challenge study is just such a wonderful way to tease all those kinds of questions out because you don't have to wait for the season. You can just infect human volunteers, line cohorts up every few weeks and dose them.

Speaker 2

So does that answer your question?

Speaker 11

Yes, that's helpful. Thank you. I have second question on the patent against the case against Pfizer because last year Pfizer said that pexelove doesn't infringe the patent because pexlovid has trifluoro group, which is not described in your patent. So if you can comment on that?

Speaker 2

Yes. I really can't get into the discussion on our ongoing patent litigation. The only thing I can say is that assuming that we're to go to trial, we would expect a trial around the end of the year.

Speaker 11

Okay. Thank you. That's helpful.

Operator

You're welcome. And thank And our next question comes from Jay Olson from Oppenheimer. Your line is now open.

Speaker 12

Hi, Jay. Thanks for providing the update and taking the questions. On the immunology program, what are the most important differentiators you're looking for with your oral KIT inhibitor candidate versus other oral KIT inhibitors in development? And how are you thinking about positioning oral KIT inhibitors versus other oral therapies for CSU such as BTK inhibitors?

Speaker 2

Thanks for the question, Jay. I'll let Tara speak to that.

Speaker 5

Sure. Hi, Jay. So I think some of the data that's been generated from the monoclonal antibodies against KIT, that would be from CellDex and then an earlier program with Jasper, had indicated that this target inhibiting this target has some of the best in disease efficacy, at least from the Phase 2 trials that have been run. So it gives us confidence in the target. And what we're really hoping for our program is to match or even exceed potentially that efficacy with a good safety profile, just with an oral route of administration.

Speaker 5

So that's the goal of our program. As you mentioned, there's other companies working on this as well. They're all early. They're all preclinical. At the moment, there's really only preclinical data at the moment.

Speaker 5

So it's hard to sort of say what would be differentiated, but I can tell you what our program is looking to achieve and that would be something that is able to be dosed QD orally, something that is very potent against kit, but selective and you know, leading to a good safety profile and just balancing that potency and selectivity so that the efficacy and safety profile could potentially be something that you would have as best in class. And then I would just say that the oral inhibitors may be more tunable. I think this is something that remains to be proven in the clinic. But whether they're able to be dosed and tuned more finally than a monoclonal antibody, you can certainly have a little bit more flexibility over that. So I think it remains to be determined, but one potential strategy as well.

Speaker 12

Okay, great. Thank you. And then can you just talk about how you're thinking about additional indications in your development plan beyond CSU?

Speaker 5

Sure. You mean for the KIT inhibitor? Yes. Yes. So, the reason that we're interested in KIT is it obviously is a key driver, for mast cells.

Speaker 5

And we know that mast cells have been implicated in a number of different indications. So certainly, chronic inducible urticaria or SINDU is something that's also been studied with this target and there's some good data from the monoclonal antibodies here. EoE or eosinophilic esophagitis is also another indication we'd be interested in. PN as well and even potentially asthma is something that one could think about with these types of inhibitors.

Speaker 12

Okay, great. That's super helpful. Thanks for taking the questions.

Operator

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

Speaker 1

Thank you, operator, and thanks to everyone for joining us today. If you have additional questions, please feel free to contact us by e mail or call the office. Have a great night.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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Earnings Conference Call
Enanta Pharmaceuticals Q2 2024
00:00 / 00:00