Earnings Call Transcript - ENTA Q2 2024

Operator, Operator

Good afternoon, and welcome to Enanta Pharmaceuticals' Fiscal Second Quarter Financial Results Conference Call. 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, Investor Relations

Thank you, operator, and thanks to everyone for joining us this afternoon. The news release with our fiscal second 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 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-K and other periodic reports filed with the SEC. 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 Dr. Jay Luly, President and CEO. Jay?

Jay Luly, President and CEO

Thank you, Jennifer, and good afternoon, everyone. Throughout 2024, Enanta 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. 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 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, 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. With this clear need, we have developed a broad clinical program that has the potential to enable multiple opportunities to treat RSV. RSV pipeline includes the most advanced clinical antiviral replication inhibitors: zelicapavir, formerly known as EDP-938, an N-protein inhibitor, as well as EDP-323, an L-protein inhibitor. Zelicapavir is currently being studied in high-risk patient populations in two Phase II studies, RSVPEDs and RSVHR. RSVPEDs is the first pediatric Phase II 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 two parts. As this is a first in pediatric study, the objective of the first part is to evaluate the safety and pharmacokinetics of zelicapavir 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 zelicapavir compared to placebo and to give confidence to move forward efficiently into larger registrational studies. A key objective of this study is to show improvement in virology endpoints in patients on zelicapavir compared to placebo, sufficient to allow us to advance into Phase III. Currently, we have partially enrolled the last age cohort of 20 patients in part 2 of the study. 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, we anticipate reporting data from this study in the second half of 2024. RSVHR is a Phase II 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 RSVHR is the 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 zelicapavir. The primary objective of this study is to show an improvement in the time to symptom resolution. Given the study was designed to be a small Phase II 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 the 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 III. Enrollment is progressing, and we will provide additional guidance on the RSVHR study as the Southern Hemisphere RSV season evolves. Also ongoing in our RSV portfolio is the Phase IIa challenge study of EDP-323, 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 1:1:1 to receive once-daily dosing of either 600 milligrams of EDP-323, 200 milligrams of EDP-323 with a loading dose of 600 milligrams on the first 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-323 is supported by positive Phase I results in which the drug demonstrated favorable safety, tolerability, and pharmacokinetics in healthy volunteers. We anticipate reporting data from this challenge study in the third quarter of 2024. We believe either zelicapavir or EDP-323 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 II study of EDP-235, a 3CL protease inhibitor, was presented in April at the ESCMID 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-19 work in the context of the 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. 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 antihistamines. But in approximately half of patients, symptoms are not alleviated, and a minority of patients are treated with one indicated biologic. 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 drivers 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 best-in-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 in preclinical development demonstrate potent inhibition and are highly selective for KIT. We continue to optimize these leads around potency, selectivity, and DMPK properties. And we are on track to select a development candidate in the fourth quarter of 2024 and plan to move into the clinic shortly thereafter. We are excited about our pipeline growth in immunology and are confident in the 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 Kowalsky 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&A activities. At Enanta, 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 IIa challenge study of EDP-323 in the third quarter and reporting data from the Phase II 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 fourth quarter. And finally, we also plan to announce a second immunology program this year.

Paul Mellett, Chief Financial Officer

Thank you, Jay. I would like to remind everyone that Enanta reports on a September 30 fiscal year schedule. Today, we are reporting results for our fiscal second quarter ended March 31, 2024. For the quarter, total revenue was $17.1 million and consists of royalty revenue earned on AbbVie's global MAVYRET net product sales. This compares to total revenue of $17.8 million for the same period in 2023. As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties for our fiscal first quarter 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% of Enanta's ongoing royalties from AbbVie's net sales of MAVYRET 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 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 as 54.5% of the cash royalty payments are paid to OMERS through June 30, 2032, subject to a cap of 1.42x the purchase payment, after which point, 100% of the cash royalty payments will be retained by Enanta. Interest expense from the debt will be recorded in Enanta's consolidated statement of operations based on an imputed interest rate. Interest expense was $2.6 million 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 $35.6 million compared to $43.5 million for the same period in 2023. The decrease was primarily due to a decrease in costs associated with our COVID-19 program as we previously announced that plans to pursue any future COVID-19 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. General and administrative expense for the quarter was $14.2 million compared to $13.8 million 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 $0.4 million for the 3 months ended March 31, 2024, for interest earned on a pending $28 million federal income tax refund compared to an income tax expense of less than $0.1 million for the 3 months ended March 31, 2023. Net loss for the 3 months ended March 31, 2024, was $31.2 million or a loss of $1.47 per diluted common share compared to a net loss of $37.7 million 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. We now expect our research and development expense to be between $125 million and $145 million, and our general and administrative expense to be between $50 million and $60 million. 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 million in 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 third quarter 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. I'd now like to turn the call back to the operator and open up the lines for questions.

Operator, Operator

And our first question comes from Akash Tewari from Jefferies.

Unknown Analyst, Analyst

This is Kathy on for Akash. So I had a question for RSVPEDs. Since RSVPEDs 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 III? 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 RSVHR? And then are you expecting a symptom benefit of like 1 or 2 days?

Jay Luly, President and CEO

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

Tara Kieffer, Chief Product Strategy Officer

Sure. Yes. So the RSVPEDs study is our proof-of-concept Phase II 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. And so the study has been done in two parts. Part one, the primary endpoint is safety and pharmacokinetics, and it's done in a dose-ascending fashion. 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 endpoints. So we're primarily again looking for improvement in virology endpoints between the patients on 938 or zelicapavir and placebo with directional data that would give us the confidence to move into a Phase III study. So we'll look at a number of different virology endpoints. 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. So there's one study that we can point to from a company that did a Phase III study in pediatrics in China. And they did show a 0.6 log drop at day 4, a statistically significant effect in virology. 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 be able to tease out these effects.

Operator, Operator

And our next question comes from Eric Joseph from JPMorgan.

Eric Joseph, Analyst

Great. I have a couple of questions regarding the immunology program for this KIT development candidate. Can you discuss your strategic plans for clinical development in this area? If you are considering a strategic partner at some point, are there specific hurdles or milestones you aim to achieve first? Additionally, I noticed that you are looking to expand with a second immunology program. Could you provide some insight into the targets you might be pursuing? Are you possibly focusing more on KIT?

Jay Luly, President and CEO

Thanks, Eric. This is Jay. We're exploring several different strategies simultaneously to determine which ones to prioritize going forward, so it's a bit early to share specifics. Regarding your question about KIT, we currently have one main program, but we're aiming to expand beyond that. We'll provide more details as the year progresses and as we gather more in-house data, produce additional molecules, and file intellectual property. Please stay tuned for updates. As for the first part of your question about strategic partnerships, our plan is to identify a candidate by the fourth quarter and hopefully move it into the clinic shortly thereafter. Phase I should be relatively straightforward. The benefit of this mechanism is that we can assess target engagement through changes in tryptase levels, which will aid us since we'll have the biomarkers we need. Clinical development in CSU should also be quite manageable, and we plan to conduct a proof-of-concept study involving a defined and sizable patient population. This approach should help us avoid the seasonal trends we faced with RSV, and we are eager to advance our first program in immunology while also considering additional targets and mechanisms over time.

Tara Kieffer, Chief Product Strategy Officer

Can I just add one thing to that, Jay? The biomarker that Jay mentioned we can monitor in Phase I in healthy volunteers is serum tryptase. There's a lot of data out there generated from some of the monoclonal antibodies against KIT 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 I studies.

Operator, Operator

And our next question comes from Ed Arce from H.C. Wainwright.

Wing Yip, Analyst

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

Jay Luly, President and CEO

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?

Wing Yip, Analyst

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 to have a ballpark percentage.

Jay Luly, President and CEO

Yes, I don't have the exact figures in front of me. Scott, could you provide more details on that?

Scott Rottinghaus, Chief Medical Officer

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. 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.

Jay Luly, President and CEO

Yes, I believe the Northern Hemisphere has a greater number of clinical trial sites compared to the Southern Hemisphere. We have a presence in various European and North American countries and also in Asia. In the Southern Hemisphere, we are present in South Africa, Brazil, Argentina, New Zealand, and Australia. While our footprint is not as large there, we are optimistic about making good progress on enrollment and completing this as soon as possible.

Wing Yip, Analyst

Understood. As a follow-up, could you remind us about the overlap between the Southern Hemisphere RSV season and flu season? Also, for the HR study, do you expect to complete enrollment in alignment with the end of the Southern Hemisphere RSV season?

Jay Luly, President and CEO

Did you ask if there is overlap with the flu season?

Wing Yip, Analyst

Yes. How much overlap is there between the RSV season and the flu season?

Jay Luly, President and CEO

Generally, they are somewhat correlated, but in any given year, they can diverge a bit. Flu might arrive a bit earlier or later, or even come around twice. Both RSV and flu, particularly RSV, have been significantly affected by the pandemic years, and they are only now starting to return to what we consider more typical seasonality. We closely monitor the RSV season compared to flu. Regarding HR, I believe we'll need to focus more on the Northern Hemisphere, as we have a much stronger presence there. We've made great progress in the Northern Hemisphere this year, making it a very favorable season for us, especially in the United States. We might need similar efforts moving forward. We will continue to track this and provide updates later this summer when we have progressed further into the Southern Hemisphere season, allowing us to make better forecasts based on more current data. That is my expectation.

Operator, Operator

And the next question comes from Roy Buchanan from Citizens JMP.

Roy Buchanan, Analyst

Just a couple on RSV. Jay, for the RSVHR, I think I heard you say that it's powered for a 50% reduction in symptoms. It's probably a high bar. Just wondering where that, I guess, conclusion about it being a high bar comes from. I think that challenge trial, you had a 75% reduction in symptoms. And are you just interpolating between that and RSVPEDs? Or is there something you're seeing in the trial?

Jay Luly, President and CEO

Yes, we are discussing the time it takes for symptoms to resolve, which differs from the challenge trial. We are comparing the number of days of improvement in symptom resolution versus a placebo. For example, in flu studies, there is typically a four-day resolution period in placebo groups, and Tamiflu reduces that by one day, resulting in a three-day resolution. This translates to a 25% improvement. Our study was designed to assess a 50% effect with just under 200 patients, and if it had been powered for a 25% effect, it would have required a larger sample size. We aimed for a balance that allowed us to conduct a Phase II trial that can support a pivotal trial while remaining manageable in size. With a few hundred patients, we believe we can make informed decisions based on clinically significant improvements, where shortening symptom resolution time by one or more days would be considered clinically meaningful.

Roy Buchanan, Analyst

Okay. Makes sense. And then for the 323 challenge, what are you hoping to see there? We've said many times that zelicapavir data is probably best-in-class. Are you expecting to see something similar? Do you need to see something similar? Just help us think about that.

Jay Luly, President and CEO

Zelicapavir does set a high standard. It functions as an N-protein inhibitor and has some of the best challenge study data any company has produced. So it represents a significant benchmark. However, 323 operates under a different mechanism as a polymerase inhibitor, which makes it very potent. The question is whether we can achieve the same best-in-class data with 323 as we did with zelicapavir. It's challenging to surpass that level. We aim to position it similarly to be considered a strong competitor in the field. From all available data, including our Phase I results that demonstrate good safety, tolerability, excellent exposure after once-daily dosing, and strong virology outcomes, we have set things up as optimally as possible. We are conducting this trial at the same clinical site as the zelicapavir trial. We expect to have data for this in the third quarter, which is next quarter.

Operator, Operator

And our next question comes from Roanna Ruiz from Leerink Partners.

Unknown Analyst, Analyst

This is Mick speaking on behalf of Roanna. To start with RSV, could you provide an update on how close you are to finishing enrollment for the younger age group in the RSVPEDs study? Also, how long do you anticipate it will take to analyze and share the data afterward?

Jay Luly, President and CEO

Yes, there are two parts to the study. The first part is complete for all age groups. The second part focuses on older age groups, and we are now down to the final group of 20 patients, which includes the youngest children aged 28 days to 6 months. We are actively recruiting this group and are in the final stages. Unfortunately, our pool of patients has decreased significantly, now only one-sixth of what it was due to age group limitations. We cannot enroll any older children in the study anymore, so our attention is concentrated on securing the remaining young children to finalize this cohort.

Unknown Analyst, Analyst

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

Jay Luly, President and CEO

We are in the process of finalizing our candidate. Our goal was to have a finalist by the fourth quarter. We are currently focused on once-daily dosing and have developed highly potent and selective molecules. We are optimizing various parameters such as DMPK profiles and tissue distribution to create the type of candidate we typically advance. We have already demonstrated strong data on a promising prototype. Our team, including chemists and biologists, is actively engaged in characterization, and our DMPK and safety team is working very hard on this. We aim to have a once-daily candidate that offers the best safety profile possible, along with good potency and selectivity.

Operator, Operator

And our next question comes from Brian Skorney from Baird.

Luke Herrmann, Analyst

This is Luke on for Brian. For EDP-323, can you remind us of your current thoughts on potentially entering a Phase IIb in otherwise healthy adults as opposed to starting with the high-risk and pediatric populations like you've done with zelicapavir? And would you wait for RSVPEDs or RSVHR data to make this decision?

Jay Luly, President and CEO

Yes, that's a good question. The short answer is we won't conduct another RSV study in otherwise healthy adults. Our RSVPED trial showed that healthy individuals resolve the infection on their own very quickly, so they don't require therapy. We will focus solely on high-risk patient populations. We expect to have a lot of data in the second half, including data on 323 and PEDs. We'll review all the information to determine the best way to position 323. Our goal has been to develop another strong mechanism for RSV and introduce a differentiated asset. This opens up the potential for combination therapies in challenging patient populations, potentially broadening the treatment window by using two drugs instead of one. This effort is part of our overall strategy to establish a leadership role in RSV therapeutics. The more options we have, the better we can leverage our assets over time. The key is to ensure we reach a strong threshold with the challenge study data first.

Operator, Operator

Our next question comes from Liisa Bayko from EVR.

Unknown Analyst, Analyst

This is Tina on for Liisa. I have a question on the 323 program. What doses of 323 are you testing in the Phase IIa human challenge study?

Jay Luly, President and CEO

Yes. We are exploring several dosing regimens. The first is a consistent 600 milligrams for 5 days. The second involves a 600 milligram loading dose on the first day, followed by 200 milligrams each day thereafter. This approach is similar to what is sometimes done with antibiotics, where an initial higher dose is administered, followed by a lower maintenance dose for a few days. We have analyzed both options, and theoretically, each has a strong potential to show the desired activity based on calculations and modeling. One regimen has a lower dose and different cost implications. The challenge study is an effective method to address these questions without needing to wait for a specific season since we can infect human volunteers and arrange cohorts every few weeks for dosing.

Unknown Analyst, Analyst

Yes, that's helpful. I have a second question about the case against Pfizer, where it was stated that Paxlovid doesn't infringe the patent because it has a different group that is not described in your patent. Could you provide some comments on that?

Jay Luly, President and CEO

I can't discuss our ongoing patent litigation in detail. However, if it progresses to trial, we anticipate it will occur toward the end of the year.

Operator, Operator

And our next question comes from Jay Olson from Oppenheimer.

Jay Olson, Analyst

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?

Jay Luly, President and CEO

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

Tara Kieffer, Chief Product Strategy Officer

Sure. The data generated from monoclonal antibodies targeting KIT, particularly from Celldex and a previous program with Jasper, suggest that inhibiting this target shows strong efficacy based on Phase II trials. This gives us confidence in pursuing this target. Our aim for our program is to match or even surpass that efficacy while maintaining a good safety profile through an oral administration route. As you noted, other companies are also developing similar therapies, but they are at an early, preclinical stage. Therefore, it's challenging to identify distinct advantages at this point. However, our program's goal is to create an oral treatment that can be dosed daily, is highly effective against KIT, and remains selective, which would lead to a favorable safety profile. We aim to balance potency and selectivity to potentially achieve a best-in-class performance. Furthermore, we believe oral inhibitors may offer more adjustability, which is yet to be validated in clinical settings. They might provide greater dosing flexibility compared to monoclonal antibodies, but this still needs to be confirmed.

Operator, Operator

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, Investor Relations

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

Operator, Operator

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