Q1 2024 Enanta Pharmaceuticals Inc Earnings Call
Participants
Ed Arce; Analyst; H.C. Wainwright & Co.
Presentation
Operator
Good afternoon and welcome to Enanta Pharmaceuticals fiscal first quarter financial results conference call. (Operator Instructions) 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.
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.
And with that, I'd like to turn the call over to Dr. Jay Luly, President and CEO. Jay?
Thank you, Jennifer, and good afternoon, everyone. In the first quarter of 2024 and then to begin an important year, which has the potential to advance our programs in both virology and immunology in 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 CSURSV. 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 infants 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 Z cap rates there and in protein inhibitor, formerly known as EDP. nine three eight and EDP. three to three and 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 Z cap of year and 80 p. three two 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 population salary cap of we are the only in protein inhibitor in clinical development is currently being studied in two Phase 2 studies of high risk patient populations.
Our SPP.s and RSVHRRSVP.s is a randomized, double-blind placebo-controlled study in hospitalized, a 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 Z cap of your safety and pharmacokinetics and multiple ascending doses to select the optimal dose for each age group.
In the second part, the objective is to evaluate Z cap of years antiviral activity at the selected optimal dose symptom scores will be assessed throughout the treatment duration. Our SVPs was designed as a smaller study that would allow us to demonstrate a trend toward improved virology metrics for semi cap a year and to also move forward expeditiously into registrational studies.
Our SVHR. 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 Sally cap of year or placebo for five days and evaluated over a 28 day period thereafter. Our SVHR.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.
We will also be evaluating multiple secondary endpoints, including other clinical efficacy measures and antiviral activity as well as pharmacokinetics and safety in our SBHR., 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 our SVPs 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 our SVP.s in the third quarter of 2024. As for our SBHR., we will provide additional guidance as the RSV season continues. Also ongoing in our ski portfolio is the Phase 2a challenge study of EDP. three two three, a highly potent L. protein inhibitor and 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 1:1:1 to receive once daily dosing of either 600 milligrams of EDP. three, two three, 200 milligrams of three to three 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. three two 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 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 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 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 is a substantial unmet need for an efficacious oral agent standard of care treatment for CSU is antihistamines.
However, in approximately half the patients symptom alleviation is not adequate. There is 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 and 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, add any 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 the 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. three two three 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 RSVP.s Phase 2 study of SLE cap of year 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?
Thank you, Jay. I would 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 31st, 2023. For the quarter, total revenue was $18 million and consisted of royalty revenue earned on AbbVie's global Maverick 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 Maverick that are included in our revenue are being paid over to owners, 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 owners until a cap of 1.42 times, the purchase payment is met.
At which 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 for 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.
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?
Question and Answer Session
Operator
And thank you. (Operator Instructions)
Roy Buchanan, JMP.
Hey, thanks for taking the questions. I just had a few on Delhi cap of their first one on the RSVP.s readout, presumably in 3Q, I guess in order the negative scenario where you don't see any biological effect, is it conceivable that you just wind down the program stopped RVHR. or would you still CRTHR. readout on and then in that same scenario, and I think the challenge trial for three to three is highly positive, would you potentially look to immediately combine the two agents, but I had a follow-up. Thanks.
And thanks, Roy. This is Jay. So I'm starting with the challenge study come three to three is also on track for Q. three. It's a very potent L. inhibitors, as you know, I know you know a lot about the data from Tom and Tom given the potency, given the TK., given the huge multiples we drive and over that protein adjusted EC. 90, were we're very hopeful that it should show efficacy, you know, comparable to a salary cap of your.
The question of getting into combination studies right away. It is an interesting one, but I think we'll probably be most interested in fully characterizing on single agent efficacy for both daily cap of year end, three to three in real world and then contemplate combinations.
Of course, in parallel, you could be scouting out some of the combinations and challenge studies, some foreshadowing that. But I think we wouldn't want to slow down some single agent characterization of some of three to three from the feed study.
Again, we're on. We're on track for q three on. You're asking an interesting question that if people didn't show anything, what would you do with a chart in our different patient populations I think you've got to look at the facts and circumstances around any clinical trial results in one patient population done under one set of conditions.
And then I'll 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 that we just need to look at data so that that's my thought on that.
Presumably HR not too far behind on that. Just as a follow-up, I wondered for nearly half of the year and if you can put a dollar value on the two markets, the feeds and the HR. Just in your view, what do you think as a rough dollar value? Thank you.
On cloud 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 to come. I'm not going to be able to give you an exact dollar amount, but it's a $1 billion. It's got to be a $1 billion market opportunity, it has $1 billion on it.
Let's just say that impedes directionally is probably the bigger piece of that. Although, Tom, I think you know, there's more data and information on RC impedes 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 home, and they're doing quite well in oh four in prophylaxis, even though only a small portion of the eligible patient population is getting I've vaccinated and everybody else, which is the overwhelming majority of people aren't getting vaccinated and we'd still be susceptible to infections.
And even some of the vaccinated people could be getting breakthrough infections. So give us more time to them to see how that market evolves a little bit. The workup final fits on a on a potential product profile, but we're very encouraged by and in our position in the in the field from the sort of the leadership position we have in our seed portfolio, POM and also the fact that there are no approved drugs on the market, huge unmet need. So it's a good opportunity.
Okay. Thank you.
You're welcome.
Operator
And thank you. Roanna Ruiz, Leerink.
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 tried 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.
Okay. Well, I'll handle part of that question and then I'll let Tara Kieffer on to our product strategy, talk about the other part. So with regards to the optimization, I think come we showed some data at JP Morgan on a prototype molecule, which we think as far along in terms of our optimization profile, we're still making lots and lots of molecules continuing to tweak have 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 come see us use attractive.
And maybe I'm already answering some questions, but we're not certainly eliminating it 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 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 and a lot of our flow and pretty much all of our programs.
And we get the biology figured out and sorted really important to do that, trying to figure out a chemical matter that we can get into hum, make sure we've got strong commercial rationale in terms of competitive landscape and potential product profiles and set all that stuff start making molecules get on the boards.
So 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?
Yes, that helps. And I have a follow-up on the RCPs as well. And so given the top line coming what do you hope to see in terms of efficacy and safety results and we use that data to inform a go or no-go decision for advancing two registrational trials?
And maybe since I didn't get Tara the chance on the last question, I'll let her take this one for sure.
Sorry to run. As you know, the RCT study on first and Peter. So doing some dose ranging and then looking at that optimal dose as part of our strategy for the primary endpoint in the second part of the study, we'll certainly look at other endpoints, clinical endpoints like symptoms and but with the size of the study will primarily be looking at it 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 that program forward into a larger, more robust Phase 3 program as we move forward. So that really what we're looking to achieve, and that's kind of initial FEED study.
Got it. Thanks.
Operator
And thank you. Akash Tewari, Jefferies.
Probably this is Stevie on for Akash. Thank you for taking your question. And it doesn't seem like the Phase 2b RSVP study is powered to hit on symptoms, their 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 Destiny or failure for Gilead at. Does that change strategic value for your protease inhibitor at all? Thank you.
We wanted to sell them.
But yes, I can build on for the RCP piece. And we will again, primarily be looking at virology. And I think on you know, there's not a lot of benchmarks in this area that we could point to or compare to there is one dataset out of a company called our file where in the Phase 3 trial they showed about a 0.6 log drop and that did translate into an improvement of statistically significant improvement on symptoms.
And so that is the one sort of benchmark that we have. But again, no numerical trends and directional data showing that those type of areas are showing an improved trend in Realogy 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, you know, it is a small study. And if the likelihood of seeing something on that, certainly a statistically significant way is probably not. And time, but we'll look at that and see what we get.
And the second part, I guess, is some switch to oral room does severe for COVID some I mean, I guess our initial reaction and we like everybody else. Just got that news late yesterday afternoon.
And I think it simplifies the COVID landscape, which is what I one of the things that I think everybody who's involved in COVID, including us and everybody who's interested in COVID, whether it's strategic city, 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 stuff one fewer now. So that's going to help clarify things. I guess she NOV is another one that's due to turnover occurred some pretty soon here. I guess there's question about what phase they're doing with their follow-on molecule. We haven't 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 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 us, they only pursue two three five in the context of a collaboration.
Okay, understood. Thank you so much. That was very helpful.
You are welcome.
Operator
And thank you. Eric Joseph, JP Morgan.
Yes, thanks.
Operator
Eric, I'm sorry. I'm you're sounding a little low there.
I'm sorry. Can you hear me now?
Operator
Yes.
Yeah. Okay. I'm basically going to question just your 3Q guidance for reading out our SDP., is that anticipate full accrual of the your target of 90 patients per year. If you've 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 time lines a bit?
Yes, I think we're still targeting to at least hit the target enrollment. That's the plan that's plan A. And a report to report data on the full set in Q3.
Okay, great. And sorry if I missed it earlier, but can you just comment a little bit on San'an, just how accrual is it taking place with our as far as the higher risk and sort of how much further behind it might be from a full accrual or how much how much further behind basically a readout from that study is tracking relative to RSVP? Thank you.
Yes. So from quarter after quarter, I've been asked which study do you think is going to readout? And I could never answer that question because you know, especially when we targeted a goal of Q3 for data. But you know, as I have said, I think at the JP Morgan conference, as we get a little further into the season, was better, a better sense of it and should be able to make a call. And clearly today we're making that call. It looks like piece is sound is the one that will come.
In terms of the HR, you know, how far behind is that? I think we just got to continue the recruitment and 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 Chris target guidance to provide it, we will.
But we did see a producer and to remind you, it's a larger study and then Pete's, right. So it's roughly twice the size we ended and it started later than feeds we but we did see a nice uptick in the Northern Hemisphere, a season that was really gratifying to see that.
So we've got over 100 sites now are in over 15 countries. We've got a pretty big catcher's mitt on now. And as you know, it's just all about execution and hoping that the trends towards normalcy, it continued. 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, so in years.
Okay. Great. That's helpful. And maybe one follow-up if I could on if you have a clear what needs to be clear evidence of reducing viral load in RSDP.? And can you talk a little bit about gating steps to running an efficacy study in the pediatric population, is that dependent on results from RS. the high-risk? Thank you.
And no, I mean there I can let Scott comment on that. But there are just very different patient populations kind of different.
Sorry. I'm Scott Rottinghaus. It's different patient populations, and we'd feel comfortable moving forward in pediatrics with positive results from our pediatric study.
Okay, great. Thanks for taking the questions.
You're welcome.
Operator
And thank you. [Jay Olson, Op Co].
This is John on the line for Jay. Thanks for taking the question and congrats on progress. And then the two questions. First, on the RSV program and just for the data cap of your if you decided to move the program into a pivotal study.
I'm just wondering how are you thinking about the adoption now our seasonal vaccine in your target patient population? And Tim would you maybe exclude patients who recently took live vaccine where there's some other thoughts around that for the moment, and that's not a question for them.
Scott, you want to take the ROC?
Yes, for sure on. So from a vaccine perspective, you know, 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 seven mAb. So we again envision a broadly studying patients in pediatrics.
You had it as helpful and done for the CF program. I'm just wondering your thoughts on how would you position the oral KIT inhibitor into DM treatment landscape for CSU? And does like a recent DDK. inhibitor read out positively. So just wondering if you think that's kind of a good benchmark for efficacy you're shooting for. Thanks.
Wireless carriers and.
Yes, thanks for the question. I guess the way we look at the CSBU 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 the layer and the data coming through from the BTK inhibitors, which are an oral option in development from this study, did readout positive. I would kind of put their efficacy to be somewhat similar to the earlier. I'm in that camp.
And what we're excited about from a KIT inhibitor perspective is the data that was generated after 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.
And so that's sort of how we're seeing this evolve and obviously, we'll continue to touch as the data comes out and hoping to provide additional efficacy over and above what a BTK inhibitor might provide.
And just maybe a quick follow-up on the last part. I think there are some like side effects for antibody approach, maybe including the kind of color change or some change in blood cells. So do you think the oral KIT inhibitor may have some advantages on safety as well?
Yeah. And so there are certainly known side effects, on-target side effects for KIT inhibitors. Overall, the antibodies had a good safety profile. Most of the AEs were mild or moderate and they resolved and the ones that are known on target that you mentioned in terms of your neutropenia.
And there were generally mild hematologic impacts and neutropenia has sort of stabilized after a short time period of 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 infection, at least in the trials with bars, though. And so we're obviously keeping an eye on it, but we don't think that will be a limitation.
Okay. Got it. Thank you so much.
Operator
And thank you. [Brian Skorney, Baird].
Hey, guys. Thanks for taking the question. This is Charlie on for Brian. Just a couple of quick ones here. Wondering if you could give us some more color on how severe symptoms are and how long RSV tends to last model thinking about pediatric and high-risk patients relative both to each other and low risk adult on such as those that were enrolled in the RSVP. trial?
And then secondly, just you spoke to antibodies and CSU. Just wondering, is this and main focus for you guys in terms of how you're about 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.
So I'll jump in on the RSV question on 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 and 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. You know the sorts of symptoms that can often get you hospitalized, so fairly severe and on with adults.
Again, the high risk adults that we're enrolling in our 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 it's the general severity and length of that disease if that helps.
And I'm sorry, could you repeat your question on CSU yet?
And that's very helpful. Thank you. On RSV. But for CSU, we are just wondering how you're thinking about designing a specificity and thinking about the antibody you mentioned earlier. Is that kind of your goal in terms of the specificity of your molecules?
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.
And we shared some preliminary data for that a few weeks ago, and we are showing good selectivity. We'll continue to optimize the compounds that we have and study them for selectivity. But that is the goal. Yes.
Thank you.
Operator
And thank you. (Operator Instructions)
Ed Arce, H.C. Wainwright.
Ed Arce
Another one of your questions. This is Thomas Yip asking a couple of questions for at. So for the new immunology program that has to be or can be later this year. I'm just trying to figure out what are some expectations that that you have for now.
Would it be for a large disease or a small disease or something along the line of the new covalent inhibitor program in terms of large market. And unless there is a large unmet, be it as well?
Yes. So we're primarily targeting on chronic spontaneous urticaria with this molecule as a primary indication.
I'm sorry, were you talking about the future to be announced program?
Ed Arce
We are excited about that? Yes, the second immunological, Rambus or to be announced this year?
Yes, certainly, yes. I mean, we're trying to be very thoughtful about going after good markets, right, good markets in areas where we think a small molecule could make a an important impact. But beyond that, we're we'll announce who commenced the program when we when we announced this.
I mean, I think kind of thing, we think about and selecting programs, obviously having a good market opportunity, something that has a high unmet medical need and 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 from are some of the criteria we look at.
Ed Arce
Got it. Thank you for the additional color. And then this question, one financial question perhaps for Paul. I'm just trying to confirm on last quarter for fiscal year 2024 OpEx guidance, R&D $100 million, $120 million, and then our G&A $45 million to $50 million just trying to figure out whether that's still on target for this fiscal year.
Yes, that is that is still our targeted spend at this point.
Ed Arce
You are professing. Thank you again for taking my questions.
Thank you.
Operator
And thank you. And I'm showing no further questions. I would now like to turn the call back over to Jennifer Viera for closing remarks.
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 on so much and have a good night.
Operator
This now concludes today's conference call. Thank you for participating. You may now disconnect.
