Q1 2023 Enanta Pharmaceuticals Inc Earnings Call
Speaker 4: and Chief Executive Officer, Paul Mellott, our Chief Financial Officer, and other members of Enantor's Senior Management Team. 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.
Speaker 5: and the answer 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 Lulai, President and CEO Jay.
Speaker 6: Thank you, Jennifer, and good afternoon, everyone.
Speaker 7: At an entire mission continues to be to leverage our expertise in small molecule drugs to discover and develop ground-breaking medicines.
Speaker 8: Our fiscal first quarter of 2023 set up a strong data-rich year, positioning us to potentially drive value for our company as we advance our expanding pipeline.
Speaker 9: Today I will start by detailing recent advances in our COVID-19 program and then comment on our broad respiratory syncytial virus, or RSV program, as well as touch base on the rest of our pipeline.
Speaker 10: Beginning with our COVID-19 program, our lead asset is CDP-235, the clinical stage, once daily, orally dosed inhibitor of the coronavirus 3CL protease.
Speaker 11: which is currently being evaluated in an ongoing Phase II study known as SPRINT.
Speaker 12: We are pleased to announce that the study has completed enrollment beyond the initial target.
Speaker 13: As a reminder, SPRINT is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of EDP-235 in approximately 200 non-hospitalized symptomatic adults with mild or moderate COVID-19 who were treated orally with 200 milligrams of EDP-235.
Speaker 14: or 400 milligrams, or placebo once daily for five days. SPRINT was designed to select a dose to move forward in development by evaluating the primary endpoint of safety and tolerability and key secondary objectives, including virologic endpoints and pharmacokinetics.
Speaker 15: Clinical symptoms and other clinical outcomes, such as rebound, will also be evaluated in more of an exploratory manner.
Speaker 16: We anticipate reporting top-line data from this study in May.
Speaker 17: Based on the study design and previous clinical data demonstrated in our Phase 1 study for EDP-235, we aim to achieve good safety, tolerability, and pharmacokinetics to support once-daily dosing.
Speaker 18: While this study is not powered on any virologic measurement, we will be looking for trends in antiviral activity as well.
Speaker 19: As COVID-19 persists and variants that circumvent immunity continue to arise globally, we are encouraged that EDP-235 has demonstrated potent antiviral activity across all SARS-CoV-2 variants tested in vitro to date.
Speaker 20: We believe EDP235 has potential to be conveniently prescribed and to treat a broader patient population. As EDP235 does not require a return of your boosting with its associated drug drug interactions.
Speaker 21: If supported by Phase 2 results, we plan to advance EDP-235 to a Phase 3 trial in the second half of this year.
Speaker 22: Beyond the positive phase one results of EDP-235, we are also encouraged by the new positive preclinical in vivo data in a FERRA model that we presented last month, which continues to add to the strong body of evidence supporting the potential of EDP-235.
Speaker 23: Findings of this study highlighted the robust antiviral treatment effect as the animals treated with EDP-235 at a rapid and sustained decline in viral load.
Speaker 24: Further results showed the ability of EDP-235 to prevent the transmission of COVID-19.
Speaker 25: When helping animals were moved into housing with infected animals that were treated with EDP235, they did not contract COVID-19.
Speaker 26: In contrast, when healthy animals were moved into housing with infected animals treated only with vehicle, they did become infected with COVID-19.
Speaker 27: We look forward to presenting the detailed findings.
Speaker 28: of our Phase 1 study for EDP-235, the results of our FERET model study, and two other preclinical posters at the International Conference on Antiviral Research, or ICAR, in March.
Speaker 29: along with pre-clinical data at the European Congress of Clinical Microbiology and Infectious Disease.
Speaker 30: or ECMID in April .
Speaker 31: Beyond ADP235, we announced a new research program to develop inhibitors for SARS-CoV-2 papain-like protease, or PLPro.
Speaker 32: We believe the addition of this program gives us multiple opportunities to combat COVID-19, and that potentially these programs may work together.
PIL-PRO is another essential enzyme which plays an important role in viral replication and in addition acts to blunt the innate immune response.
Inhibition of PL-Pro blocks viral replication and has the potential to alleviate the suppression of the immune response to SARS-CoV-2 infection.
As this mechanism is distinct from 3Cl protease inhibition, has the potential to be used alone or in combination with 3Cl protease inhibitors such as EDP-235 or other compounds to provide a range of treatment regimens for different patient populations suffering from COVID-19.
Our prototype inhibitors demonstrate nanomolar potency against the Omicron variant in both biochemical and cellular assays, and we continue to optimize inhibitors as we progress this program forward toward development candidate selection.
Continuing with our industry leading respiratory virology treatment portfolio, we're progressing in our broad RSV program, which includes EDP 938, the most advanced end protein inhibitor in clinical development, as well as EDP 323.
are novel oral therapeutic targeting RSV L-protein RNA polymerase.
Our goal is to develop an effective therapeutic for RSV that provides a cure for the populations that are severely affected by this virus.
EDP-938 is being evaluated in multiple phase 2 clinical studies, including RSV-HR, a phase 2B study in adults with acute RSV infection who are at high risk of complications, including the elderly and or those with congestive heart failure, COPD, or asthma.
RSVP is a phase 2 study in hospitalized and non-hospitalized pediatric RSV patients.
and RSV-TX, a phase 2B study in adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection.
These three studies are expected to continue through 2023, and we'll continue to monitor the RSV epidemiology to evaluate the impact on trial enrollment and timing for these data readouts.
Also in RSV, last quarter we announced a dosing of the first subject in the phase one study of our L protein inhibitor EDP323.
This ongoing double-blind placebo-controlled first-in-human study is designed to enroll approximately 80 healthy subjects to evaluate the safety, tolerability, and pharmacokinetics of Orally administered single and multiple doses of EDP 323.
We believe both EDP-938 and EDP-323 could serve as standalone treatments or be used in combination regimens to broaden the treatment window or addressable patient populations for RSV.
We look forward to presenting preclinical pharmacokinetic data on EDP-323 at ECMID and expect to report top-line Phase I data next quarter.
Moving on to our respiratory discovery program, we're excited to recently announce our novel broader spectrum and eviral research program targeting both RSV and human metanumovirus or HMPV with a single agent.
HMPV and RSV are similar viruses.
Both are important causes of respiratory tract infections and are endemic globally, impacting several vulnerable populations including children, the elderly, adults with underlying cardiopulmonary disease, and those who are immune compromised.
We're encouraged by preclinical findings in which our prototype dual inhibitor demonstrated potent nanomolar activity against multiple genotypes and strains of both viruses and a range of cell types.
Further, our prototype dual inhibitor, a potently inhibited replication of both HMPV and RSV in a dose-dependent manner in respective mouse models, demonstrated a significant reduction in viral load of both viruses.
A dual inhibitor provides the potential for a broader spectrum antiviral that would allow respiratory infections diagnosed as either HMPV or RSV to be treated with a single agent.
We continue to optimize our potent tool inhibitor and aim to select a clinical candidate in the fourth quarter of this year.
Turning to hepatitis B, we are cognizant of the continued high end need for this disease.
as it is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer.
We are focused on identifying different mechanisms of action and alternative compounds to develop in combination with EDP-514, our potent core inhibitor, and an existing nucleoside reverse transcriptase inhibitor, which we believe can ultimately be important components of a successful combination regimen.
Finally, I'd like to wrap up by highlighting our near-term milestones.
Again, we are thrilled with the progress of EDP-235 for the treatment of COVID-19 and plan to announce top-line data from our Phase IIB study, SPRINT, in May, and pending results, initiate a Phase III study in the second half of this year.
We plan to report top-line data from our Phase 1 study of EDP-323, our RSV L inhibitor, next quarter.
And we look forward to presenting data on our RSV and COVID programs at the I-CAR in March and ECMED in April .
With that, I'll turn the call over to Paul to discuss our financials.
Thank you Jay. For the quarter, total revenue was $23.6 million and consisted primarily of $22.6 million of royalty revenue earned on Avi's Global Maverick Net Product sales.
This compares to a total revenue of 27.6 million for the same period in 2021.
The decline is primarily a result of continued lower treated patient volumes due to the COVID pandemic.
Royalty revenue was calculated on 50% of Maverick sales at a royalty rate for the quarter of 12%, after adjustments for certain contractual discounts, which are now approximately 2% of Avi's total reported HCV product sales.
You can review our royalty schedule in our 2022 Form 10-K .
Moving on to our expenses, for the three months ended December 31, 2022, research and development expenses totaled $40.9 million compared to $48.5 million for the same period in 2021.
The decrease was primarily due to the timing of drug supply manufacturing and preclinical studies in the company's virology program year over year.
General and administrative expense for the quarter was $12.7 million compared to $9.5 million for the same period in 2021. This increase was primarily due to an increase in headcount and related stock-based compensation expense.
Net loss for the three months ended December 31, 2022, was $29 million, or a loss of $1.39 per diluted common share, compared to a net loss of $30.1 million, or a loss of $1.48 per diluted common share, for the corresponding period of 2021.
and end of the quarter with approximately $241.4 million in cash and marketable securities.
We expect that our current cash, cash equivalents, and short-term and long-term marketable securities, as well as our ongoing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs into the fourth fiscal quarter of 2024.
Further financial details are available in our press release and will be available in our quarterly report on form 10Q when filed.
I'd now like to turn the call back to the operator and open up the lines of questions.
operator
Thank you sir.
As a reminder to ask a question please press star 11 on your telephone and wait for your name to be announced.
To withdraw your question, please press star 1-1 again.
And please stand by while we compile the Q&A roster.
We ask that you keep your questions to no more than one, but please feel free to go back into the queue and at time permits, we'll be more than happy to take your follow-up questions at that time.
I show our first question comes from the line of Joe Kim from RBC. Please go ahead.
Hi, this is Joe, I'm for Brian . Thanks for taking my question. I just wanted to quickly ask here on your latest view on the COVID outlook and what sort of evolving market opportunity you're seeing in COVID. Yeah, that's my question. Thank you.
Sure, thank you. This is Jay. So, regarding the outlook.
You know, it's been certainly a rough few years in terms of the pandemic, and I think there's a migration to the endemic phase of this, but we we see it as a tremendous opportunity.
that will probably, you know, ultimately settle down to be something more than flu.
And obviously there's several different angles you can.
Think about playing with a product like EDP-235 over the longer term. You can think about high-risk patient populations. You can think about standard risk patient populations.
You can also think about possibilities in long COVID and also from a post-exposure of prophylaxis perspective. And so all of these are potential avenues to build over time and to grow.
But we don't see this virus going away anytime soon, if ever, and that it's likely to persist in a very meaningful way in a public health.
Perspective So.
Thank you.
Welcome. Our next question comes from the line of Yasmin Rahimi from Piper Sandler.
Hi, this is Emma on for gas. Thanks for taking our questions. We are wondering that based on your market research, how cumbersome is the return of your boost for tax love it and what is the appetite among physicians?
for EDP 235 adoption. Thank you.
Well I think,
You know, ritonavir is definitely not a desirable. You know, ultimately it adds complexity. You're trying to treat a respiratory virus.
with a respiratory viral drug, a protease inhibitor, and you're adding an HIV protease inhibitor just to boost the drug levels in the case of Paxilovid. So it's really the boosting agent.
that leads to many drug-drug interactions as it relates to ritonavir. Ritonavir also has a taste problem.
And
We, Paxilovit as it's currently being administered is three pills in the morning, three pills in the later part of the day, and then four or five days, so it's 30 pills in total. The doses that we're selecting
in our sprint study for evaluation, either of those we believe can ultimately be formulated into a single tablet, which could be one pill once a day based on the pharmacokinetics that we've observed.
and phase one healthy clinical trials. So, you know, if we can achieve one pill once a day with a very potent and effective drug and not have a boosting agent that leads to lots of drug drug interactions and complexities for physicians.
That's an attractive product profile.
everywhere we've checked.
We compile the next question.
And I show the next question comes from the line of Brian Squarney from there. Please go ahead.
Hi, this is Luke on for Brian since sprint excludes elevated risk patients. Would you have to do any additional safety work before going into a pivotal in a higher risk setting?
Not necessarily. I think.
You know, certainly Pfizer went from phase one healthies into high risk. I recognize that was
at an earlier time.
But, you know, we're.
currently in discussions with regulatory agencies, but at this time there's no reason to suspect.
a different safety profile of the drug in that patient population.
Next question. Thank you. And I show next question comes from the line of Rona Ruiz from SBB Securities. Please go ahead.
Hi, thanks for taking the question. So maybe tagging on to some of the COVID questions, I was curious about your new PL-Pro mechanism antiviral. How do you expect that to fit into the treatment landscape in the future, especially when it's possible, there could be multiple 3CL protease inhibitors available.
No one has approved drugs for. So when we started working early on in the pandemic, we went after multiple mechanisms, including 3CL Pro and PL Pro. 3CL Pro gave rise to our first candidate, sooner than PL Pro. But at the end of the day, no one's really...
had the opportunity to study a PL-Pro in clinical trials. So whereas there may be multiple 3-CL pros across the line, ultimately, again, we think the best product profile will win longer term. But.
We also wonder out loud, you know, could a PL-Pro have other advantages over a 3-seal Pro? We know that...
PLPro, like 3CLPro is a
is a critical enzyme in viral replication. So either protease inhibitors should be able to knock down the replication part of it. But PLPro also has a role in blunting the innate immune response of the host.
And we wonder if there couldn't be some extra impact that you could have in a treatment by having a PL-Pro inhibitor that not only shuts down replication, but may also block the suppression of that innate immune response.
So in this sort of a situation, more drug choices are better than fewer. We don't believe at this time that there's any reason to believe that...
combination on top of a 3Cl Pro is necessary, but that might not always be the case.
And also...
There may be special patient populations where you'll want to have two drugs to try to help the person rather than just one. So for all these reasons...
and especially where we are in fully understanding this virus. It's good to have multiple shots on goal. And we think the PL Pro is really interesting. We've got some great chemical matter and we're pushing as hard as we can to bring that forward as a candidate.
Thank you. And our next question comes from the line of Akash Tiwari from Jefferies. Please go ahead. Okay.
Hi, this is Amy on SirCosh, Simpson for taking our question. On this sprint trial, I know you indicated that it's not powered to show viral load reduction, but I would love to hear any sort of color on what it is powered to show in terms of symptoms benefit or any other and points that you think is relevant.
And what are you specifically looking for in the data in order to move forward? And additionally, what are the big inflection points in your view where you're looking to partner out the program ideally? Thanks so much.
Yeah, so—
I think all this sort of hangs together. You know, the primary endpoint is we've disclosed previously is safety and tolerability. It was not powered on these other parameters. It certainly wasn't powered on a symptomatic readout.
But nonetheless, these are things that you look at as secondary endpoints to gather as much information as you can in terms of what factors, you know, what symptoms might have been modulated the most.
with this current variant that the drug was tested against. So this is all important information to capture as you're planning phase three. We'll also be looking for trends in viral loads to help us select a dose.
Typically with these protease inhibitors...
You know, you see...
You know, maybe about a log. You don't see profound viral load drops the way these things are measured in these studies, but nonetheless with a trial that's roughly around 200 patients, we did over enroll the study.
But I think hopefully it's set up to give us what we need to know about safety and tolerability between doses, look for trends in the virology between the doses. And anything else we can get out of this study is gravy, so to speak, as we're planning phase three studies.
So this data is obviously what we're trying to achieve in the Sprint data and you indicated this one's a bad.
You know, what's appropriate for a partner, you know, partners always have what they want to see, but suffice it to say.
you know, the data package that we're putting together continues to build into something that's very interesting and perhaps best in class.
Thank you. And I show our next question comes from the line of Matthew Herschenhorn from Oppenheimer. Please go ahead.
Okay, this is Matt on for Jay Olson as well. Thank you so much for taking our questions. So we were wondering for the HMPV RSV dual inhibitor, could you just talk about the potential utilization in the real world? How common, for example, is it for patients to have a co-infection?
And also, how will the dual inhibitor impact EDP-938 and EDP-323 development? Really appreciate it. So we need to support some programs to Gross is to further of a research and to understand other programs that may be Space IT.
Sure, thanks for the question. So the dual inhibitor, to be clear, we're not looking for co-infected patients. Although they could exist, I think that would be a relatively rare thing. It might be more common to be infected with COVID and RSV or COVID and human metapneumo, but even that...
Co-infection in these specific instances is probably rather rare. So instead, the way we're thinking about it is more of a broad spectrum antiviral one that we could use to treat either infection so that...
Regardless of whether it was RSV or human metanummo in the diagnosis, you could just use one drug to take care of both of them.
RSV is also of hours that most
pediatricians can tell an RSV infection just based on, you know, bronchiolitis and other sorts of symptoms.
So, you know, someday it might even be used to treat patients presumptively for those infections and having the comfort that you could treat either RSV or human metapneumo would be a great advantage.
I'll kind of go back to my earlier point. When we get into an area...
we don't
We don't usually just pick on one mechanism for a drug or one drug class. We like coming forward really understanding, especially in an area like RSV and human metapneumo where there are no approved drugs. We want to have as many different mechanisms and classes that we can bring forward.
Ultimately, there will be comparative data that we'll have. We may elect to select them into different patient populations.
And in some instances, there may be reasons to do combinations. You didn't ask about our health protein inhibitor for RSV-323, but that's another mechanism that we have in addition to 938.
So we have a lot of optionality going forward. Thank you. And I show our next question. Come from the line of edRc from HC Wainwright and Co. Please go ahead.
Hi, Jay. Thanks for taking our questions. Really just one on EDP-323 in RSV with data in the second quarter, as you mentioned. Just wondering, this study is obviously in Human Sciences. This is just another conversation between assessment, health, and Rare Services
So there's really no opportunity yet for neurological data. But I'm just wondering what kind of, what criteria are you looking at? How should we judge this early safety and PK study result?
How would you judge it to move forward? And as you think about next steps, when do you think we could get initial efficacy data? Thanks.
Thanks, Ed. Yeah, so 323 data in Q2. It's a standard phase one and healthy.
trial, but the good news is when it comes to virals that tells you an awful lot and can in fact do a lot of de-risking of the asset as you know. So we'll be looking at safety, PK, and then we'll be looking at the risk of COVID-19.
especially PK, not that safety is unimportant, but PK is where you really dial in your dose selection for future studies. And there we always aim for a once daily dosing. That's always our target. So we hope to achieve.
once daily dosing that gives adequate trough level concentrations at the 24-hour time point to deliver good pressure on the virus in terms of multiples of the EC90.
So, if we can do all of that, that's certainly what we've done with.
you know, or other antivirals. And our preclinical modeling, you know, suggests that we've picked doses to to achieve that in this study. So we'll soon enough know the answer to that. And then assuming that the data are good, you know, you can think about
you know probably the quickest way to get any viral data would be to do a challenge study which you can also use to...
you know, check antiviral effect, you can look at symptoms, and you can also further redefine any dose decisions that you might be wanting to make for other more advanced studies.
So, I think that's the broad layout for the year.
Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.
And I show our next question comes from the line of Eric Joseph from JP Morgan. Please go ahead.
Good evening. Thanks for taking the questions.
Just a couple on 235 and COVID. I'm wondering if there's a clear sense of.
the types of endpoints that would be needed to support registration for a COVID-19 viral just given where we are with vaccine exposure and prior virus exposure has it been any any shift I guess from the precedent sent by Pax-Lovid and Lazareo and UNI-HUMAND ERC not restore vaccine or SIM address prior FDA
And then secondly, assuming compelling data from Sprint, I just want to get a sense of the sequencing of events from here between partnering and launching the Phase 3 study. And I guess specifically whether your cash guidance through fourth quarter next year anticipatesper
full execution of the phase three trial, whether you could go it alone. Thanks for taking the questions.
Yeah, so I think we're setting ourselves up to...
collect sprint data. It's as expected, having discussions with the regulators to design that Phase 3 study. There's lots of different
possibilities in terms of how you could think about that in terms of end points. Maybe I'll let Tara Keefer here elaborate on that a little bit further. But with regards to
you know, partnering, you know, will that timing will be that timing and I'm not gonna.
You know, commingled that with Sprint Phase III start or data collection. So we'll give updates on each of those tracks, you know, as updates are relevant. From a cash perspective, we would position ourselves to be able to do this.
But right now, I think we feel reasonably good about that. So maybe I'll turn the call off to Dr. Tara Kiefer here. She's our Senior Vice President of New Product Strategy and Development. We've been thinking a lot about phase three stuff along with our clinical team.
about possible endpoints and so forth. Again, we will ultimately select it after discussions with the agency, so nothing that we're going to declare today, but there's different possibilities. Tara?
Sure. Thanks, Jay. Hi, Eric. Thanks for the question. This is Tara. So I think, you know, if you think about phase three trials for COVID, there's a number of different strategies that one could think about, including different patient populations. So a high-risk patient population, standard risk population. There are currently phase three studies going on in both of those populations. Also one that...
on those that a subset that have a higher risk and really elevating that event rate.
you know, other endpoints that are being used are looking at symptoms. So Shinogi has an ongoing phase three trial now that's looking at a symptom endpoint. And they had shown data from their other phase three trials being run in Asia where they did see a significant effect on symptoms.
looking at a subset of five symptoms that were shown in their phase 2B study to be more correlated with an effect. So I think there's a number of different strategies one can use. We're obviously thinking about all of those among others and having discussions with regulatory agencies as we move forward to our next phase.
Thank you. And I see our next question comes from the line of Roy Buchanan from JMP Security. Please go ahead.
I guess a one on 514, any changes to your confidence in the capsid inhibitors? It doesn't sound like it, maybe more concretely, are you shifting to look more externally or internally versus your prior?
I'm just thinking J&J's comments around their hepatitis B program, GSK going into phase three with just an ASO and a nuke. Any change to your thinking? Thanks.
No change to the thinking. I think corn, habitors are still.
an impactful class of HPV drug. I think ultimately, whereas we're doing a little bit internally, we're looking externally at the landscape for other possible options. But I also think it's,
It's important while we're in sort of this phase to be thinking about other datasets that are going to be ultimately coming from others which may inform.
potential other combination ingredients.
I would say we're not in a hurry to push something ahead just to do it. We're being very thoughtful and disciplined on this front, or unless we've come up with that solution. But the only way we will be able to get a solution not only is through the republican government, but the government of Canada that we are in.
you know, we're not going to just push a dual acting regimen forward in clinical development and spend that money and manpower on it. So, I think it's going to be a little bit more watching and analyzing. And a little bit of doing.
And I show our next question comes from the line of Akash Tiwari from Jefferies. Please go ahead.
Hi, this is Amy again. Thanks so much for taking our follow-up. Just wanted to get your thoughts on, so Pfizer recently made some interesting comments that competitor COVID antivirals won't be on the market until around 2025, and they could show worse efficacy because of the lower event rates. Would love to get your thoughts on these comments.
Well, you know, it's anything is possible. I think PaxLovid today, if you put it in a clinical trial, would show probably a lower event rate as well. But you, again, you can never know how to speculate on that. I think the variants continue to.
to change, I think people will be looking at different things. But at the end of the day, we think you can show clinical significance in important patient populations.
And with an easier to use drug that doesn't have some of the liabilities I mentioned earlier on the call. So either way I think there's going to be room for other drugs out there that are more conveniently dosed.
Thank you. And I show our next question. It comes from the line of Brian Scorny from Bayer. Please go ahead. Good evening from products management I have seen clearly related inventors today and
Okay this is lukecran there. Just one more for us. On spring criteria, is there any reason to expect meaningfully different antiviral or clinical impact and patients treated after five days of symptoms, as opposed to someone who goes in and gets treated on day 1? And is that a cross-section you'll look at when you cut the data?
We'll have a little bit of a cut in terms of timing on that. I think it's less than three days versus greater than three days up to five days. So, you know, we'll see what we see. In general, almost always.
The earlier you treat is more optimal, but COVID has been a little bit more forgiving than some other viruses. So we'll just wait and see. We'll collect the data and look at it. And again, that'll help inform how we progress.
Thank you.
And I do show we have another question from Roy Buchanan from JMP Security. Please go ahead.
Okay, thanks for taking a thought. Jay mentioned some combo.
that you're tracking, data readouts that are coming up. Can you tell us what those are?
Maybe I'll turn that over to Tara. You're talking about an HBV again? Yes. Thanks.
Sure, Roy Hayet's Tara. So we'll certainly be looking at all of the combination studies that are going on out there today. So that would include Roche's larger trial that is looking at combinations that they have with their SIRNA and... ...and...
and immune modulators. Also, VIR is running a number of trials now with their SIRNA, as well as looking at therapeutic vaccines. They're also doing a trial with their monoclonal antibody combination, and also one with interferon. And then they're additionally looking at one with a TLR8.
from Gilli, that's in combination with Gilli-Ed. Our previous, as a couple of ongoing, they have an SIRNA in combination with interferon, so we'll be looking at that trial as well. GSK obviously is moving forward with their ASO alone in in combination with interferon, so we'll be...
Thank you, operator, and thanks to everyone for joining us today. If you have additional questions, feel free to contact us by email or call us at the office. Thanks and have a good night. Bye-bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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