Enanta Pharmaceuticals (NASDAQ:ENTA), a biotechnology company focusing on the development of treatments for viral infections and liver diseases, reported its fiscal first quarter financial results, underscoring progress in its key programs and providing financial updates. The company is advancing its respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU) programs, with important clinical trial results expected in the third quarter of 2024. Financially, Enanta reported $18 million in total revenue for the quarter, with $337 million in cash reserves, which are expected to support operations through fiscal 2027.
Key Takeaways
- Enanta is progressing with its RSV program, including zelicapavir and EDP-323, both with fast-track designation from the FDA.
- A KIT inhibitor treatment for CSU is in development, with a candidate expected to be announced this year.
- Phase 2a study results for EDP-323 and Phase 2 study results for zelicapavir are anticipated in the third quarter of 2024.
- Enanta plans to unveil a second immunology program in 2024.
- The company reported $18 million in revenue and a net loss of $33.4 million for the quarter.
- Current cash reserves are projected to fund operations through fiscal 2027.
Company Outlook
- Enanta expects to present a development candidate for its CSU program within the year.
- The company is set to announce a second immunology program targeting diseases with high unmet medical needs and clear clinical paths.
Bearish Highlights
- Total revenue for the quarter saw a decrease from the same period in the previous year, down from $23.6 million to $18 million.
- The company reported a net loss of $33.4 million for the quarter.
Bullish Highlights
- Enanta's R&D programs are advancing, with fast-track designations for its RSV treatments.
- The company maintains a strong cash position with sufficient funds to support planned operations for the next several years.
Misses
- Revenue fell short compared to the same quarter in the previous year.
- The company experienced a significant net loss during the quarter.
Q&A Highlights
- The company discussed the design and specificity of its CSU program, emphasizing the development of a potent and selective molecule targeting KIT.
- Enanta is focusing on programs with strong market potential and is prepared to announce a new immunology program later in the year.
Enanta Pharmaceuticals (ENTA) has provided a comprehensive update on its operational progress and financial standing during its latest earnings call. The company has highlighted its ongoing efforts in developing treatments for RSV and CSU, with significant clinical trial milestones expected in the coming year. Despite a decrease in revenue and reporting a net loss for the quarter, Enanta remains confident in its financial health, with a robust cash position that is anticipated to fund its operations well into the future. The company's strategic focus on diseases with high unmet medical needs and clear clinical paths underscores its commitment to addressing significant health challenges. As Enanta prepares to introduce a new immunology program and advance its current pipeline, investors and stakeholders will be watching closely for the outcomes of the upcoming clinical trials and the potential impacts on the company's growth trajectory.
InvestingPro Insights
As Enanta Pharmaceuticals (ENTA) navigates through its clinical developments and financial milestones, real-time data and insights from InvestingPro provide a deeper look into the company's current market standing and future prospects.
InvestingPro Data metrics show a market capitalization of $259.37 million, signaling the company's size in the biotech landscape. A notable P/E ratio of -1.95 reflects the company's current lack of profitability, which aligns with the net loss reported for the quarter. Moreover, despite a decrease in revenue by -8.07% over the last twelve months as of Q4 2023, the company's gross profit margin remains at 100%, indicating that its cost of goods sold is very low or non-existent.
InvestingPro Tips suggest that Enanta holds more cash than debt on its balance sheet, which corroborates the company's statement of having sufficient cash reserves to support operations through fiscal 2027. This is a critical factor for investors considering the financial stability and longevity of the company, especially as it does not pay dividends to shareholders. In addition, two analysts have revised their earnings upwards for the upcoming period, which may indicate a positive outlook on the company's future performance.
It's important to note that while Enanta has shown a strong return over the last three months with a 39.32% increase, the price has fallen significantly over the last year, with a -76.72% return. This volatility highlights the importance of staying informed with the latest market data and analyst insights.
For those looking to delve deeper into Enanta's financial health and market potential, InvestingPro offers additional tips. There are currently six more InvestingPro Tips available, which can be accessed by visiting https://www.investing.com/pro/ENTA. To enhance your investing strategy with these insights, use coupon code "SFY24" to get an additional 10% off a 2-year InvestingPro+ subscription, or "SFY241" to get an additional 10% off a 1-year InvestingPro+ subscription.
The reported financials, combined with InvestingPro's real-time data and insights, provide investors with a comprehensive understanding of Enanta's position as it continues to advance its RSV and CSU programs.
Full transcript - Enanta Pharmaceuticals Inc (ENTA) Q1 2024:
Operator: Good afternoon and welcome to Enanta Pharmaceuticals' Fiscal First Quarter Financial Results Conference Call. At this time, all participants are on 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 Viera, Investor Relations. Please go ahead.
Jennifer Viera: 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 Dr. Jay Luly, President and Chief Executive Officer; and Paul Mellett, our Chief Financial Officer. Dr. Scott Rottinghaus, our Chief Medical Officer; and Dr. Tara Kieffer, our Chief Product Strategy Officer, will be available during the Q&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-K, 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 Dr. Jay Luly, President and CEO. Jay?
Jay Luly: Thank you, Jennifer, and good afternoon, everyone. In the first quarter 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 treatments 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 first quarter, 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. 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 zelicapavir, an N-protein inhibitor, formerly known as EDP-938, and EDP-323, 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. We believe both zelicapavir and EDP-323 have robust potential as monotherapies, but we're also excited by the opportunity, to combine them and potentially broaden the treatment window for addressable patient populations. Zelicapavir, the only N-protein inhibitor in clinical development, is currently being studied in two Phase 2 studies of high-risk patient populations, RSVPEDs and RSVHR. RSVPEDs is a randomized, double-blind, placebo-controlled study in hospitalized and non-hospitalized pediatric RSV patients aged 28 days to 36 months. It is a two-part study of approximately 90 patients. The objective of the first part is to evaluate zelicapavir's safety in pharmacokinetics in multiple ascending doses, to select the optimal dose for each age group. In the second part, the objective is to evaluate zelicapavir's antiviral activity, at the selected optimal dose. Symptom scores will be assessed throughout the treatment duration. RSVPEDs was designed as a smaller study that, would allow us to demonstrate a trend toward improved virology metrics for zelicapavir and to also move forward expeditiously into registrational studies. RSVHR 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 zelicapavir or placebo for five days and evaluated over a 28-day period thereafter. RSVHR'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 RIIQ, Symptom Score Scale. We will also be evaluating multiple secondary endpoints, including other clinical efficacy measures, and antiviral activity, as well as pharmacokinetics and safety. In RSVHR, we are primarily looking to see a clinically meaningful improvement in time to symptom resolution. 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 RSVHR 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 from RSVPEDs in the third quarter of 2024. As for RSVHR, we will provide additional guidance as the RSV season continues. Also ongoing in our RSV portfolio is the Phase 2a challenge study of EDP-323, 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 one-to-one-to-one to receive once-daily dosing of either 600 milligrams of EDP-323, 200 milligrams of 323 with a loading dose of 600 milligrams on the first day, or placebo for five days. Primary and secondary outcome measures include safety, changes in viral load measurements, and changes in symptoms from baseline. We advanced EDP-323 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 third quarter of 2024. 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. Patients with CSU also experience 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 two to five years, although some reports estimate that more than half of the patients suffer for more than five 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's a substantial unmet need for an efficacious oral agent. 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. 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 antibodies 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. We are very excited about our pipeline growth in immunology and are pursuing additional targets, with plans to introduce a second immunology program this year. With that, I'd like to conclude by highlighting our upcoming milestones. We look forward to reporting results from our Phase 2a challenge study of EDP-323 in the third quarter of 2024. And assuming the season continues to be a normal RSV season in the Northern Hemisphere. We anticipate reporting data from the RSVPEDs Phase 2 study of zelicapavir in the third quarter of 2024. Further, we plan to identify a clinical candidate for our CSU program this year. 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?
Paul Mellett: Thank you, Jay. I'd like to remind everyone that Enanta reports on the September 30 fiscal year schedule. Today, we are reporting results for our fiscal first quarter ended December 31, 2023. For the quarter, total revenue was $18 million and consisted of royalty revenue, earned on AbbVie (NYSE:ABBV)'s global MAVYRET net product sales. This compares to total revenue of $23.6 million, for the same period in 2022. As a reminder, 54.5% of Enanta's ongoing royalties from AbbVie's net sales of MAVYRET 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 million recorded as a liability. As such, we continue to record 100% of the royalties earned as revenue, and will then amortize the debt liability proportionately as 54.5% 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% of the cash royalty payments will be retained by Enanta. Non-cash interest expense of the debt will be recorded in Enanta's consolidated statement of operations, based on an imputed interest rate. Interest expense was $3.4 million for the three months ended December 31, 2023. Moving on to our other expenses, the three months ended December 31, 2023. Research and development expenses totaled $36.4 million, compared to $40.9 million for the same period in 2022. The decrease was primarily due to a decrease in costs associated, with our COVID-19 program, as we previously announced that our plans, to pursue any future COVID-19 efforts, would be in the context of a collaboration. General and administrative expense for the quarter was $16.5 million, compared to $12.7 million 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 (NYSE:PFE). Other income net totaled $0.9 million. Enanta recorded an income tax benefit of $0.6 million for the three months ended December 31, 2023 for interest earned on a pending $28 million federal income tax refund, compared to an income tax benefit of less than $0.1 million for the three months ended December 31, 2022. Net loss for the three months ended December 31, 2023 was $33.4 million, or a loss of $1.58 per diluted common share, compared to a net loss of $29 million, or a loss of $1.39 per diluted common share for the corresponding period in 2022. Enanta ended the quarter with approximately $337 million in 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, through fiscal 2027. Further financial details are included in our press release and will be available in our report on Form 10-Q when 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. [Operator Instructions] And one moment for our first question. And our first question comes from Roy Buchanan from JMP. Your line is now open.
Roy Buchanan: Hi, thanks for taking the questions. I just had a few on zelicapavir. First one on the RSVPEDs 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 RSVHR, or would you still see RSVHR readout? And then in that same scenario, and if the challenge file for 323 is highly positive, would you potentially look to immediately combine the two agents? Then I have a follow-up? Thanks.
Jay Luly: Thanks, Roy. This is Jay. So starting with the challenge study, 323 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. 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 zelicapavir. The question of getting into combination studies right away is an interesting one. But I think, we'll probably be most interested in fully characterizing single-agent efficacy for both zelicapavir and 323 in real world and then contemplate combinations. Of course, in parallel, you could be scouting out, some of the combinations in challenge studies, foreshadowing that. But I think we wouldn't want to slow down single-agent characterization of 323. 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? Different patient populations, I think you've 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. So, we just need to look at data. So that's my thought on that.
Roy Buchanan: Okay. Great. Presumably, HR is not too far behind. Just a follow-up, I wondered for zelicapavir, if you can put a dollar value on the two markets, the PEDs and the HR, just in your view. What do you think is a rough dollar value? Thank you.
Jay Luly: 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 $1 billion market opportunity. It has $1 billion on it, let's just say that. And PEDs directionally, is probably the bigger piece of that, although I think, there's more data and information on RSV in 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. So, give us more time to see how that market evolves a little bit, work up final bits on a potential product profile. But we're very encouraged by our position in the field, sort of the leadership position we have in RSV portfolio, and also the fact that there are no approved drugs on the market to each unmet need. So it's a good opportunity.
Roy Buchanan: Okay. Thank you.
Jay Luly: You're welcome.
Operator: And thank you. And one moment for our next question. And our next question comes from Roanna Ruiz from Leerink. Your line is now open.
Roanna Ruiz: 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? And I have a follow-up after that?
Jay Luly: Okay. Well, I'll handle part of that question, and then I'll let Tara Kieffer, Heads our Product Strategy, talk about the other part. So with regards to the optimization, I think we showed some data at JPMorgan 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 in to every one of our molecules. 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 first 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. And we tend to do all of that, before we really announce a 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?
Roanna Ruiz: Yes, that helps. And I have a follow-up on RSVPEDs 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 registrational trials?
Jay Luly: Yes, maybe since I didn't give Tara the chance on the last question, I'll let her take this one.
Tara Kieffer: Sure. Yes, of course. So, Roanna, as the RSVPEDs study, first in P, so doing some dose ranging, and then looking at that optimal dose at virology, so 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 endpoints. 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 the program forward into a larger, more robust Phase 3 program as we move forward. So that's really what we're looking to achieve in this kind of initial team study.
Roanna Ruiz: 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.
Amy Li: Hi, this is Amy on for Akash. Thank you for taking our question. It doesn't seem like the Phase 2b RSVPEDs 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 death severe failure for Gilead? Does that change strategic value for your protease inhibitor at all? Thank you.
Jay Luly: You want to take this one like.
Tara Kieffer: Yes, I can build on - for the RSVPEDs piece. Yes, 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. But again, numerical trends and directional data showing that zelicapavir 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 a statistically significant way is probably not as high, but we'll look at that and see what we get.
Jay Luly: Okay. 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 its strategics or the government. We'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. I guess, Chianogi is another one that's due to turn over a 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 a question mark there that will hopefully get sorted here in the nearer term. And then, we'll have a more complete view of what that competitive landscape 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 collaboration.
Amy Li: Okay. Understood. Thank you so much. That was very helpful.
Jay Luly: You're welcome.
Operator: And thank you. And one moment for our next question. And our next question comes from Eric Joseph from JPMorgan. Your line is now open.
Eric Joseph: Oh, thanks. Just a quick...
Operator: Eric, I'm sorry. You're sounding a little low there.
Eric Joseph: I'm sorry. Can you hear me now?
Operator: Yes, sir.
Eric Joseph: Yes. Okay. Thanks for taking the question. Just your 3Q guidance for reading out RSVPEDs, does that anticipate full accrual of your target of 90 patients? If you sort of end up tracking under that goal after this season, do you go ahead with a readout, or do you perhaps sort of push out timelines a bit?
Jay Luly: No, I think we're still targeting to, at least hit the target enrollment, that's the plan, that's plan A. And to report data on the full set in Q3.
Eric Joseph: Okay. Great. And sorry if I missed it earlier, but can you just comment a little bit on just how accrual is taking place with RSV high risk and sort of how much further behind it might be, from a full accrual, or how much further behind basically a readout from that study is tracking relative to RSVPEDs? Thank you.
Jay Luly: 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 target as a goal of Q3 for data. But as I said, I think at the JPMorgan conference, as we get a little further into this season, we'll have a better sense of it and should be able to make a call. And clearly today we're making that call. It looks like PEDs, is the one that will. In terms of the HR, how far behind is it? I think we just got to continue the recruitment in that. 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 it, we will. But we did see it. And to remind you – since it's a larger study than PEDs, right? So it's roughly twice the size. And it started later than PEDs. But we did see a nice uptick in this Northern Hemisphere season. It was really gratifying to see that. So, we've got over 100 sites now. We're in over 15 countries. Yes, we got a pretty big catcher's mitt on now. And - it's just all about execution and hoping, 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 first season we've seen like this in years.
Eric Joseph: Okay. Great. That's helpful. Maybe one follow-up, if I could. If you have a clear, what seems to be clear evidence of, reducing viral load in RSVPEDs? Can you talk a little bit about gating steps running an efficacy study in the pediatric population? Is that dependent on results from RSV high risk? Thank you.
Jay Luly: No, I mean there, I can let Scott comment on that. But they're isn't, they're just very different patient populations. Scott, I don't know.
Scott Rottinghaus: Sorry, Scott Rottinghaus, it's different patient populations. And we'd feel comfortable moving forward in pediatrics with positive results from our pediatrics study.
Eric Joseph: Okay. Great. Thanks for taking the questions.
Jay Luly: 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.
Unidentified Analyst: Hi, this is John [indiscernible] for Jay. Thanks for taking the question. I'm glad some progress. Maybe two questions for us. First on the RSV program. Just for zelicapavir, if you decide to move the program into a pivotal study, 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? Were there some other thoughts around that for the moment? And I have another question for the CSU program?
Jay Luly: Hi, Scott, you want to take the RSV?
Scott Rottinghaus: 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 [indiscernible]. So we again, envision broadly studying patients in pediatrics.
Unidentified Analyst: You had it. That's helpful. And for the CSU program, I'm just wondering your thoughts on how would you position the oral KIT inhibitor into the treatment landscape for CSU? And there's like recent BDK inhibitor that are positively. So just wondering if you think that's kind of a good benchmark, for efficacy you're shooting for? Thanks.
Tara Kieffer: Hi, this is Tara. 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 BDK inhibitors, which are an oral option in development. 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 option. So that's sort of how we're seeing this evolve. Obviously, we'll continue to watch as the data comes out, hoping to provide additional efficacy over and above what a BDK inhibitor might provide.
Unidentified Analyst: 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 hair color change or some change in blood cells. So do you think the oral KIT inhibitor, may have some advantage on safety as well? Thanks.
Tara Kieffer: 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 your neutropenia, there were generally mild hematologic impacts, and the neutropenia sort of stabilized after a short time period of a week or two of dosing. And so, what we did find out is that 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 thus far, though. And so, we're obviously keeping an eye on it, but we don't think that will be a limitation.
Unidentified Analyst: Okay. Got it. Thank you so much.
Operator: 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.
Unidentified Analyst: Hi, guys. Thanks for taking the question. This is [Charlie] on for Brian. Just a couple 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 RSVPEDs trial. And then secondly, just you spoke to antibodies and CSU. Just wondering, is this a main focus for you guys in terms of how you're designing the specificity of your lead candidate? And do you consider that a bar for you to reach? And how else are you thinking about that? Thank you.
Scott Rottinghaus: 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 two 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. So that's, I think, the general severity and length of that disease. If that helps.
Jay Luly: And I'm sorry, could you repeat your question on CSU?
Unidentified Analyst: 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?
Tara Kieffer: 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 preclinically 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 susceptivity. But that is the goal, yes.
Unidentified Analyst: Thank you.
Tara Kieffer: You bet.
Operator: And thank you. [Operator Instructions] And one moment for our next question. Ed, our next question comes from Ed Arce from H.C. Wainwright. Your line is now open.
Unidentified Analyst: Hi, everyone. Thank you for taking my questions. This is Thomas, asking a couple of questions for Ed. So for the new immunology program that is to be unveiled later this year, just try to figure out, what are some expectations that you have for now, whether it be for a large disease or small disease, or something along the line of the new KIT inhibitor program in terms of large market. And then lastly, a large unmet need as well?
Tara Kieffer: Yes. So we're primarily targeting chronic spontaneous urticaria with this molecule as a primary indication.
Jay Luly: I'm sorry. Were you talking about a future to be announced program?
Unidentified Analyst: Yes. The second immunology program that's to be announced this year?
Jay Luly: Yes, so we - yes, I mean, we're trying to be very thoughtful about it going after, good markets, right? Good markets in areas where we think a small molecule could make - an important impact. But beyond that, we'll announce the program when we announce it.
Tara Kieffer: 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 underlying disease, cause of the disease and having confidence in the target and mechanism are some of the criteria we look at.
Unidentified Analyst: Got it. Thanks. Thank you for the additional color. And the next question, one financial question, first of all, just trying to confirm last quarter for fiscal year 2024, OpEx guidance, R&D $100 million to $120 million and then, G&A $45 million to $50 million. Just trying to figure out whether that's still on target for this fiscal year?
Paul Mellett: Yes, that is still our targeted spend at this point, yes.
Unidentified Analyst: All right. Fantastic. Thank you again for taking my questions.
Tara Kieffer: 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 Viera for closing remarks.
Jennifer Viera: Thank you, everyone, for joining us today. If you have additional questions, please feel free to contact us either by email or call the office. Thanks so much and have a good night.
Operator: This now concludes today's conference call. Thank you for participating. You may now disconnect.
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