Q3 2023 Enanta Pharmaceuticals Inc Earnings Call
Good afternoon, and welcome to an anti pharmaceuticals fiscal third quarter financial results Conference call. At this time all participants are in listen only mode there'll be a question and answer session at the end of the prepared remarks, please be advised.
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 and the news release with our fiscal third quarter 2023 financial results was issued this afternoon and is available on our website, making formal remarks on today's call are Dr. J, Lullay, President and Chief Executive Officer and Paul.
Paul Mellett, our Chief Financial Officer, Dr. Scott Rottinghaus, our Chief Medical Officer, and Dr. Guitar, Keefer, our senior Vice President of New product strategy and development 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, which.
They 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-Q and other periodic reports filed with the SEC Anantha 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 <unk>, President and C E O J.
Thank you Jennifer and good afternoon, everyone.
At Anantha, we're committed to our mission of being a leader in the development of groundbreaking therapeutics for viral infections.
And this quarter, we made important strides to bring us closer to impactful inflection points and ultimately our goals.
I am proud of the work our team has accomplished this quarter and throughout the year, so far across our pipeline and business, most notably in our respiratory syncytial virus.
RSV program and our COVID-19 program.
We're in a strong position to continue to advance our pipeline and I am confident in our clothes efforts to progress antiviral small molecule medicines to treat life threatening viral infections.
Today I'll provide an overview of our progress during the third quarter beginning with our RSV program, then I'll comment on our COVID-19 program and the rest of our pipeline.
RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in children.
Early in the immune compromised.
RSP has received a significant amount of attention recently with the approvals of new vaccines in monoclonal antibodies.
Prevent severe infection.
However, given the experience with Covid and flu vaccines, including limited adoption of breakthrough infections, we believe it's safe and effective oral RSV anti viral medications can bring significant value to patients infected with RSV.
Starting with our most current update we recently announced positive data from the phase one trial of Edp 323 in healthy volunteers as a reminder, ADP three Q3 is our al protein inhibitor in development as a once daily oral treatment for RSV with fast track designation from.
The FDA.
That's phase one study enrolled healthy volunteers to evaluate the safety Tolerability and pharmacokinetics of oral edp three to three and single ascending doses and multiple ascending doses for seven days along with the effect that occurred.
The third phase enrolled a total of six cohorts ranging and goes from 50 to 800 milligrams.
Mad phase enrolled four cohorts with doses ranging from 200 to 800 milligrams.
Edp three Q3 was found to be generally safe and well tolerated up to the highest dose tested at 800 milligrams over seven days.
Most adverse events were mild and there were no serious or severe adverse events.
It was one study just confirming that.
Turning away from due to syncope.
It's deemed unlikely to be related to edp three.
Edp three two pre exposure increase with increasing in single and multiple dose up to 600 milligrams with a half life ranging from 11% to 17 hours.
<unk> once daily dosing Edp.
GDP pre Q3 doses Greenfield come 200 to 800 milligrams once daily resulted in strong EC 90 multiples against FERC RSV <unk> screens and.
When administered for seven days were found to result in <unk> 24 concentrations at steady state.
744 fold over protein adjusted <unk> 90.
Three nanometer work.
Against.
RSV, a and B screen.
Additionally, no food effect was observed with a high fat meal, suggesting that edp 323 can be administered without regard to crude.
We are pleased with this encouraged from a safety and pharmacokinetic data and virology when a potent antiviral such as Edp 323 achieved high multiples of EC 90 safely it as a very positive signal in an important derisking steps for the program.
These data and enhance our belief in ADP <unk>, three as a potential therapeutic and give us the confidence to continue to progress the program.
We believe Edp three Q3 could serve as a standalone treatment or be used in combination with other agents such as Edp 938.
The treatment window or addressable patient population for RSV.
We plan to initiate a human RSV challenge study evaluating Edp 323 early in the fourth quarter and we anticipate having results in the second quarter of 2024.
Our broad RSV program also includes Edp 938, the only N protein inhibitor in clinical development, which we are currently evaluating in multiple phase III studies as a potential treatment in high risk patient populations.
These studies include RSVP.
Phase two randomized double blind placebo controlled study in hospitalized or non hospitalized pediatric RSV patients.
RSV HR.
To be randomized double blind placebo controlled study in adults with RSV infection, who are at high risk for complications, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease or asthma.
And RSP Etfs, a phase <unk> randomized double blind placebo controlled study in adult hematopoietic cell transplant recipients with RSV symptoms of upper respiratory tract infection.
Enrollment for RSVP RSP HR at RSP, TX is ongoing and we are utilizing sites in both the northern and southern hemispheres to optimize our coverage of potential RFP searches.
If there is a return to a normal pre pandemic type of RSP season in the northern Hemisphere, we expect to complete enrollment in one or more of these studies and the upcoming northern hemisphere season and to have data in fiscal year 2024.
Turning to COVID-19, we announced additional analyses from the phase two Sars Cov, two sprint study, which built upon our positive top line results that we announced in May of this year.
<unk> three five is our clinical stage once daily orally dosed inhibitor of Corona virus, three CL protease that was evaluated in sprint.
Randomized double blind placebo controlled phase II clinical trial, and 231 adults with milder moderate COVID-19, who did not have risk factors for progression to severe disease.
Patients received 200 or 400 milligrams of Edp, three five or placebo orally once daily for five days.
And the Phase III study Edp 305 was found to be generally safe and well tolerated.
Statistically significant dose improvement and sometimes was observed in the 400 milligram cohort starting as early as one day following the first dose.
In a predefined subset of patients enrolled within three days of symptom onset a statistically significant dose dependent improvement in symptoms was observed at all time points and a two day shorter time to improvement was observed.
Subset of six symptoms and the 400 milligram cohort compared to placebo.
Additional analyses as announced in June demonstrated a viral logic effect of Edp 305, and the subset of patients who have not recently been infected as measured by lack of antibodies to the Sars cov two nucleocapsid.
When we refer to as nucleocapsid negative patients.
Specifically in nuclear caps had negative patients 0.8 log decline in viral load was observed at day five with 400 milligrams of Edp three five compared to placebo in a one log viral load decline at the five and the subset of nucleocapsid negative patients who were treated within three days.
After symptom onset.
Looking ahead, our current plan is to conduct all future COVID-19 work in the context of a collaboration.
In particular, we continue to focus on progressing Edp 305 into phase III trials with our partner and gaining regulatory feedback that further enable and partnership.
Moving onto our dual inhibitor research program targeting each MPV and RSV, we plan to select a clinical candidate in the fourth quarter of this year.
In preclinical studies, our prototype dual inhibitor potently inhibited both each on PV and RSV replication in a dose dependent manner, demonstrating a significant reduction in viral load of each virus.
Maintains an animal or activity against multiple genotypes and strains of each in PV and RSV and a range of cell types.
Our dual inhibitor as broader spectrum antiviral that would allow respiratory infections diagnosed as either H MPV or RSV, both of which are significant causes of respiratory tract infections globally to be treated with a single agent aging population such as children and the elderly who are at greatest risk.
In hepatitis B, we continue to monitor the field for compounds to develop in combination with Edp 501 for our potent core inhibitor with FDA fast track designation and a nucleoside reverse transcriptase inhibitor.
We believe the core inhibitors, such as Edp 514 will ultimately be an important component of a successful combination regimen and that can potentially help us address the high level of unmet need in HBV.
Finally, looking beyond virology.
We're piloting new programs that leverage our core strength in small molecule drug discovery and look forward to sharing more details on these growth areas with you in the coming months.
I'd like to wrap up by highlighting our near term milestones.
Ken we are thrilled with the progress of Edp three to three and the positive results from our phase one study and we plan to advance <unk> into a human challenge study early in the fourth quarter, we anticipate having results in the second quarter of 2024.
We plan to announce the selection of a dual inhibitor of clinical candidate targeting both <unk> and RSP in the fourth quarter of this year.
And if there is a return to a normal pre pandemic type of RSV season in the northern Hemisphere, we expect to complete enrollment in one or more of our phase III studies of Edp nine create and the upcoming northern hemisphere season and have data in fiscal year 2024.
With that I'll turn the call over to Paul to discuss our financials Paul.
Thank you Jay for the quarter total revenue was $18 9 million and consisted of royalty revenue earned on <unk> Global Maverick net product sales. This.
This compares to total revenue of $19 5 million for the same period in 2022.
In April 2023, we sold 54, 5% of our ongoing Maverick royalties from Abbvie for an upfront payment of 200 million from <unk>, one of Canada's largest defined benefit pension plans.
For financial reporting purposes, the transaction will be treated as debt with the upfront purchase payment of 200 million paid to us being recorded as a liability.
And that will continue to record 100% of future royalty payments as revenue and we will then amortize the debt liability proportionately as royalties are paid to all amongst until a cap of 142 times the purchase payment is Matt <unk>.
<unk> expense will be recorded in our consolidated statement of operations as other expense based on an imputed interest rate.
Moving onto our expenses for the three months ended June 32023 research and development expense totaled $43 million compared to $39 1 million for the same period in 2022.
The increase was due to the timing of clinical trial expenses and overall itchy programs.
General and administrative expense for the quarter was $12 6 million compared to $12 9 million for the same period in 2022.
And natural recorded income tax expense of $4 2 million for the three months ended June 30th 2023, driven by the receipt of the $200 million from the royalty sale agreement, which is taxable for federal and state purposes.
<unk> was able to utilize federal net operating loss and research and development tax credit carry forwards as well as the deduction for foreign derived intangible income to substantially offset the taxable effect is the royalty sale agreement.
For the three months ended June 32022, and <unk> recorded an income tax benefit of <unk> 4 million, which was due to the release of a state tax reserve during the period.
Net loss for the three months ended June 32023 was $39 1 million or a <unk>.
Loss of $1 86 per diluted common share compared to a net loss of $31 7 million or a loss of $1 53 per diluted common share for the corresponding period in 2022.
And then at the ended the quarter with approximately $392 5 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 should be sufficient to meet the anticipated cash requirements of our existing business and development programs and to the second half of fiscal 2027.
Driven by changes to our Covid clinical development plans, we are reducing external spending.
To that end, we've updated our guidance for fiscal 2023.
And I would expect our research and development expense to be between $165 million and $175 million.
General and administrative expense to be between $50 million and $55 million.
Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed.
I would now like to turn the call back to the operator and open the lines up for questions.
Thank you.
To ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, please standby, while we compile the Q&A roster.
Our first question will come from Brian Abrahams with RBC capital markets. Your line is open.
Hi, there. Thanks, so much for taking my questions. Just a couple of questions from me first off.
On the RSV program in <unk> and.
<unk> three.
Given that the PK.
Data that safety data that you saw with with <unk> three in healthy volunteers I'm curious if you could maybe elaborate a little bit more on your latest views on the combinability and complementarity between <unk> three and 93 eight and then had a follow up thanks.
Sure. Thanks.
Thanks, Brian This is Jay.
The 32 393 eight.
We've studied them pre clinically.
Look at their combined ability and pre clinically they behaved very well.
Together once an inhibitor, that's 90 381 and <unk> inhibitor that's 323.
So we don't expect.
Any issues with combinability from.
From an interaction standpoint.
Think.
I think the real question is as you know.
Will we need to combine them.
Where will we ultimately want to combine them in certain patient populations and those are the kinds of things that are going to take a little bit.
Longer to sort out.
Number one we believe that 93 eight as a standalone.
Yeah.
Could well have all the horsepower we need in a garden variety RSV.
323 could also perform very well as a single agent will get more insights into that as we get data from the upcoming human Challenge study.
But I guess the question is this mountain to you want or need to combine them in a certain very difficult to treat patient population and thats something that we can.
Certainly explore that.
Down the road or Mike do you want to combine them.
To see if you could open up a treatment window that would be wider than either agent alone again thats something that we can look at down the line is where.
Optimizing the.
The category so.
Those are the.
The initial thoughts right now.
Got it.
That makes a lot of sense, thanks, Jay and then.
On.
Covid program.
Can you help us understand the implications of the data you recently reported showing those viral load reductions.
Nucleocapsid negative patients should we think about that as.
<unk> speaking to a subpopulation that could down the line.
Uniquely targeted ball or just more as further evidence.
Biological evidence of the mechanism here and I guess, where do you stand in terms of the regulatory path forward can you maybe speak to.
Some of the.
The pads, you're exploring as it might is still involved.
Additional phase two work moving right into phase III, perhaps exploring long COVID-19 as well thanks, I'll hop back in the queue.
Yes, so the patient population that you're referring to I think it's the nucleocapsid negative patient population.
These are people, who haven't had a recent COVID-19 infection or haven't had one at all.
That's sort of a unique.
Antigen that you can look at to determine whether or not someone's.
Again had the virus somewhat recently I think one of the takeaways that we cleaned from our further analysis of the data is.
It's hard to measure.
The relative changes in the nose of people who have more recently been infected.
And when you look at the patient population, who hadn't been most recently effect that you could measure.
Viral load changes and the new.
Knows.
As time goes on probably everybody who hasn't been in fact, it is going to be impacted and.
Yes.
So variously that's kind of.
Sort of challenge the ability to.
Look at that measurement of viral load change in the nose.
But that doesn't.
That doesn't tell you anything close to the whole story.
Because what really matters is the viral load changes that are happening elsewhere in the body where sites of infection can can set up shop in the respiratory tract and in other tissues. So.
We feel that Thats more.
Horton thing overall this is why FDA has not.
Sort of embraced using viral load endpoints.
Path to approval, but rather to focus on.
Sometimes and outcomes as it relates to.
To Covid and <unk>.
Section so looking at sometimes where as you know in the sprint data, we had very nice dataset on sometimes and then ultimately.
That endpoint.
Probably changes to hospitalization and deaths in certain patient populations that are at high risk. So.
I think thats.
Our takeaway from that.
Data set and as I look forward.
It really doesn't change I think.
How are you.
Progressive drug through registration studies again, that's all going to be based on <unk>.
Symptoms.
They're kinds of end points.
With regards to registration we are in.
Communication with the.
The regulators.
And this is not just in the us but.
Elsewhere.
Really getting the latest thinking on <unk>.
Pathways to approval and different kinds of trial designs. So.
Those discussions are in progress.
And then.
As we said before.
Any next study is our plan to be.
Ducting that study in the context of a.
Our partnership so.
That's ultimately as our as our plan is to identify that phase III and commercialization partner.
And and.
Do so.
Hopefully with greater insights from the latest thinking of the regulators in terms of pathways to approval.
Makes sense. Thanks, so much Jay.
Welcome.
Thank you.
Our next question.
Comes from Jay Olson with Oppenheimer. Your line is open.
Oh, hey, thanks for taking the questions.
Curious about the three RSV phase II study is currently enrolling for 938.
Can you talk about the enrollment speed interest level, and which one is gaining the most attention.
Then for 2024 update do you expect to provide each phase II readout, one by one as the results become available or will you wait until they are all complete and disclose all the results together and if you do choose to read them out sequentially, what would be the read across from one trial to another.
A follow up if I could.
Sure. Thanks, Jay This is Jay.
We have the.
The three phase twos for Edp 938.
Up and running.
Kind of.
<unk> doubled down on the footprint of trial sites.
Not a robust RSV season, exactly now we're sort of between.
Season saw though that we're still seeing activity.
In the southern Hemisphere.
We have sites.
Down in Brazil, and Argentina.
New Zealand, Australia, South Africa.
And then in the northern Hemisphere were.
And another 10 countries waiting for.
The virus to come north so.
Big footprint, it's hard to know.
Exactly because theyre very different patient populations. So peds is sort of one.
Sort of.
The circumstances and trial size the adult high risk is a different one yet and then.
Bone marrow transplant recipients are very different patient population so.
Each is going to proceed at its own pace I think the only thing that I would say is transplant.
Probably the hardest because youre again, asking for a few different.
Not that common things to happen one is to have a bone marrow transplant, and then others to get RSV and a very careful lockdown world for bone marrow transplant recipients, where they're extremely cautious so I think.
If I were.
Again, you can't truly predict but I would predict that.
Transplant will be.
Flagging behind the other two with the other two.
Again, we've got.
We're in 15 countries.
And Pete I think we have over 70 sites now active.
In the adult transplant or I'm, sorry on the adult high risk we've got over 100 sites active and we are just waiting for the virus to come back this fall and hopefully have.
Not really.
For the sake of the trials anyway.
Robust.
Sort of a standard north American or northern Hemisphere, I should say.
Season, because we're throughout Europe .
We're in the Middle East we're in.
Asia.
And obviously all across North America.
When it comes to reporting out we're not going away, we're not going to harvest all three at once so will read them out.
As they.
As a as they come.
Okay great.
I guess as you look ahead to the phase III studies for 938.
How will the adoption of the RSV vaccine play a role in your phase III strategy.
Yes sure.
Yes, there is a vaccine and monoclonal antibodies, maybe all of that.
Turkey for speak.
Speak to that one.
Sure Hi, Jay this is Sarah so.
In terms of the.
Vaccines that have been recently approved in adults.
We don't anticipate that having much of an impact both GSK and Pfizer have guided toward minimal.
Cake, but their vaccines at least initially in the first season so.
Just by way of example.
GSK has sort of guided to.
<unk>.
Less than what they saw with <unk> in the first year so that was.
Say, 7% in the first full year.
So we don't we don't expect that to have too much of an impact.
Okay, great. Thank you for taking the questions.
Youre welcome.
Thank you one moment for our next question.
Okay.
We have a question from Ed Arce with H C. Wainwright Your line is open.
Hi, Jason Thanks for taking our questions.
I wanted to start with the RSV program 323.
And in the recent.
Uh huh.
Results from your phase one, including the PK.
Supportive of once daily.
I missed the.
<unk>.
<unk> 90 multiples that you stated as well as the nano model minimal upholding potency.
And then beyond that I just wanted to ask.
If you could opine on how we should think about benchmarking.
Relative to potential other.
Agents in development or indeed, how to hand.
Indicate where handicap the probability of success.
Okay.
Okay.
So thanks, Ed This is Jay so the potency.
Edp 300 to three again SSD L inhibitor, it's extremely potent it's <unk> three nanomole or so 300.
<unk> in terms of an inhibitor.
That's good.
It's a good but not.
Not necessarily sufficient what you want to see is obviously, good PK and safety.
So those were the two other things that we clicked off in the phase one study so.
And the <unk>.
Doses, we looked at.
200, 400, 600 800, so a.
A range of 200 to 800 milligrams and we when we looked at the 24 hour trough time point after a single dose.
At the low dose we saw multiples that were 11 X.
<unk> 90.
<unk>.
At the high dose we saw multiples that were 44 ex the EC 90, So just walking.
Whopping multiples.
That very potent <unk> hundred 90, and we were able to do that in a manner that was very safe and well tolerated. So.
I know Ed you've focused on infectious disease for a long time.
When you have.
An agent, where you know that potency it takes to sort of take out the bug and you can deliver those concentrations are high multiples that those EC <unk>.
Safely.
With either antibacterial as our Antivirals, it's usually a very.
A significant de risking step along the way so I think.
It bodes well.
The next proof in the pudding I guess goes to when we.
Get inside that human challenge study, which again will be starting.
Early next quarter.
And with that we'll actually be able to look at antiviral effects.
Areas.
At various doses so.
Stay tuned for that.
Hopefully that will enroll fairly straightforwardly, because the human challenge study.
Recall is in healthy volunteers that we.
And in fact with RSP. So it's not a question of seasonality its really just a question of <unk>.
Bringing in cohort after cohort of healthy volunteers to Q2 your exploration.
So.
That'll be the next step where we actually show hopefully some very solid.
Antiviral activity.
Great.
Sure.
I agree that the.
These these early readouts to give a lot of confidence in the correlations to actual.
Patient results.
The other question I had.
Was around.
The Covid program.
And I believe this is a.
A new sort of decision.
To look for partnerships.
For phase III once you've completed the ongoing study.
Wondering if.
The rapid drop in Covid vaccine demand.
As described recently by both Pfizer and Mcdonough.
Impact.
<unk>.
The potential of that program, either for out licensing or or otherwise.
Well a reduction in vaccination.
Only lead to an increase in.
Infection, where you need an antiviral so.
We've always believed this to be the case ultimately.
Vaccines would never have 100% efficacy.
I had five vaccinations and still got Covid.
Sure.
So there is never 100% efficacious.
And compliance is never 100% and we've seen that compliance drop way way off.
Meanwhile.
Covid is.
Yes, COVID-19 levels, right now or a little.
They are pretty pretty low.
<unk> this creep up a little bit here in Boston as we watch the wastewater everyday.
<unk>.
There is still pretty low, but we'll see what happens.
In the fall as we get.
Closer to the sort of the normal.
Season, So I think ultimately.
We all know believes that the virus is not going away, it's going to go back into.
Sort of being like.
Nasty flu and we need drugs for that.
So I think.
Yeah.
It's actually not new news that our.
Our decision on the.
The partnering front I mean, we made that.
I think it's pretty clear last.
Last quarter.
And even before that.
Telegraphed for.
Really since the beginning of the pandemic that our ultimate aim is to.
Find that commercial partners that would really handle the late stage work and give us a global footprint that we couldnt, possibly achieve as well a loan where we to do it. So that's that's still our plan, we will see what happens to the.
The virus starting in the fall.
I appreciate your comments thank you.
Youre welcome.
Thank you.
And our next question.
Comes from Eric Joseph with Jpmorgan. Your line is open.
Thanks for taking my question just actually sticking with.
<unk> point about benchmarking for Edp 323, I guess.
What type.
Data Readouts from the human Challenge study would kind of give you an indication of the molecule is.
Differentiated perhaps from <unk> 48.
Would you, perhaps including forget is in fact, a comparator in that trial.
Just more jet.
Generally with respect to the trial design is there any are there any key differences.
The design.
Yes.
<unk> hematology study compared to that conducted in 2019 for <unk>.
Thank you.
I think we're going to use the same hour chat to conduct this study.
I think you should be thinking of this study is being.
Very very much.
Same design.
And I think the.
Wanted to the world's best benchmark to look at it as Edp 938.
That was one of the most robust datasets ever.
Ever.
Performed in a are achieved in a.
A human challenge study so.
93, <unk> will be the standard that will compare it to we're not going to do.
Sort of a side by side in this.
Study that's.
That would only drag it out further.
And postpone the time for us to.
Get into.
Later stage studies with the molecule I think.
We've got such a good handle on that challenge data.
And how to look at that challenge data that we'll be able to get pretty much everything we need to know from just the.
The drug versus placebo and to remind you.
93 eight.
A data that we showed with that was extremely robust antiviral effect, so pretty much within 12 hours of dosing 93, eight it altered the course of the infection. So people who were on 93 eight had viral loads that started too.
Stabilize in decline and people on placebo.
<unk> continued to rise and plateau and only after many days.
Return back towards normal so.
It was a highly statistically significant anti viral effect that we achieved versus placebo and the same was.
The exact result.
When you looked at it was achieved with symptoms scores as well so.
From a symptom standpoint within a day of dosing.
Sometimes had stabilized and started to go down.
Whereas people on placebo.
<unk> continued to progress that got worse.
They plateaued at.
Elevated level and then only gradually resolved over time.
So that's the kind of data that we're looking for.
Again, we've got a very <unk>.
Excellent benchmark comparator with Edp 938.
Thank you one moment for our next question.
We have a question from Roy Buchanan with JMP. Your line is open.
Hey, Thanks for taking the questions a couple on 235 any publications or presentations of details from the sprint.
Data expected later this year.
That's the timing on that is subject to getting presentations accepted a conferences so well.
We are planning presentation of the data.
So what I will say is stay tuned on that front with regards to timing and we will certainly announce.
The time and place in the venue once we've been accepted for presentation.
Okay, Great and then anything you can give us on the tone of the part of your discussion for three five.
As he mentioned cases that are pretty low in the U S at least.
People are waiting to see how that plays out. This winter you also mentioned regulatory.
Uncertainty maybe is that a gating factor or anything you can tell us about that.
Not in any degree of specificity.
But you hit on.
Interesting pets that are not only on our minds, obviously partners think about these things to trying to.
Xactly size.
What the market is and understand.
As clearly as they can what that regulatory pathway as we can.
We can't control.
What the infection looks like.
In a given season, but what we can try to do is green.
Clarity from regulators in terms of pathways. So.
We're working on the part that we can control right now.
Okay, Great and then one last one on 501 for this mechanism for combination are you looking at things that are already out there and being tested by our CLR random choice.
Or are you pretty much through those already and are you looking at something completely novel, maybe hasnt been in the clinic, maybe even from an academic lab.
Okay.
We're very we've looked at a lot of the usual suspects.
That are out there I mean, obviously the.
<unk> are out there people have looked at.
Various.
Arnie I approaches and whatnot, we haven't we haven't grabbed onto <unk>.
What we think is necessarily the right mechanism yet so we're still monitoring the field, it's a little bit frustrating that there aren't a lot of.
Sort of profound new steps forward in this.
And in this field of HBV.
So.
Right now.
It's a little bit of a holding pattern as I've said before we're not going to.
Throw other agents and to create the triple combo.
Until we have a great deal of confidence that it's a study where the funding so in the meantime.
We're we're hunting is still.
Okay. Thank you.
Youre welcome.
Thank you.
Our next question.
It comes from.
Cash.
To worry from Jefferies. Your line is open.
Hey, this is Amy I'm, sorry, hi, thanks, so much for taking our question.
First question on Edp, three tends to be what percent of that drug is <unk>.
Down to plasma protein in vivo and.
And Additionally, do you expect any safety risks from targeting RNA polymerization, we've seen neutropenia with lupus decitabine, but note that the niche.
<unk>, which is a little different but would love to hear your thoughts here.
Yes, I don't recall the level of protein binding but.
The ratio or the multiples of the EC 90 that I quoted earlier, which ranged between 11 and 44 fold we're already adjusted for that protein binding so.
Whatever the protein binding is this is multiples on top of that when you look at it from a free drug perspective.
And Youre correct <unk>.
Being a new a lot of the nukes in the field had.
Issues.
Nukes.
Not uncommonly.
Suffer.
Benefit from I guess, depending upon how you look at it.
Broad.
Activity across other polymer aces.
So.
Deal activity can be a problem.
But edp 300, <unk> three is a.
Non nuke polymerase inhibitor and so far.
Clinical safety <unk>.
Excellent.
Human safety in terms of safety and Tolerability at least from our Phase. One study was also very very strong.
Great.
On.
Q3, five are there any additional datasets that a potential partner would be looking for to support a collaboration and then when do you expect to get clarity from the regulatory perspective on path to registration.
So I think right now we have the clinical data that we have.
With regards to the sprint study again, we saw.
Antiviral effect, we saw effect on symptom improvement.
So those are the data that we have in the as I mentioned the regulatory discussions are ongoing.
One we will finish those there'll be done when we're done with the exchanges. So.
It's hard for me to put a time point on that right now but.
We will have further updates as we progress.
Great.
And then finally, one last one on cash runway can you go over the main drivers for you extending runway from 2026 last quarter to 2027 now outside of the owners royalty sale are there any other ongoing portfolio prioritization activities that we should be aware of.
Well as we've indicated this is Paul Miller.
We've made the decision to wait.
Wafer partnering situation to continue the phase III work on two or three size and Thats a significant.
Extension of our runway for the most part and that's the primary driver.
And then obviously.
We have not discussed any potential revenue or anything like that from a partnering arrangement. It's just simply the expense sparing of the phase III trials.
Got it thank you so much.
Thank you.
Our next question.
It comes from Brian <unk> from Baird. Your line is open.
Hey, this is Luke on for Brian Thanks for taking the questions.
First on <unk> three any consideration with regard to the human challenge study designed to maximize potential read through to real world populations.
And then just a second one on HBV and RSV dual inhibitor.
As you finalize selection of that candidate is there any consideration of potential compromises that make the candidate more or less able to potently inhibit either virus or are tradeoffs not really a necessity in this situation.
Yes so.
<unk> three this is Jay 323.
The challenge study again.
That's the challenge study, it's the sort of rite of passage for RSV.
<unk> everybody puts them through the challenge study and for the most part everybody runs the challenge study.
And a very similar way so that you can.
Cross trial comparisons are always.
Never.
Perfect our ideal but to the extent that you can.
Compare data in this setup, it's helpful to run it in the same way so.
Not every molecule that goes into a challenge study comes out successfully.
From a challenge study so it's not a given.
We view it as a yes.
That's a good next step and one that again further de risks things because if you come out of the challenge study with really robust.
Data.
Know that you have a good anti viral.
And in a human setting so.
You put that in your in your back pocket.
And then with regards to human meta Pneumo RSV dual.
I don't.
There is not really not sure I fully understand your question I mean there.
We have.
Again, we've we put data out on a on a prototype we're aiming to have our final.
Candidate or candidates finalized in Q4.
You can never exactly balance potency.
I suspect you could try to do that maybe for your.
For the rest of your life trying to get everything exactly balanced, but that doesn't kind of matter because you always.
Whenever you have a broader spectrum drug.
There's always a dose defining pathogen, which is the one that you are the least potent against.
And that if you dose for that account for that.
Be good against the in this case, the other pathogen, which has even greater potency. So.
We're optimizing.
Different.
Characteristics of the molecule in that.
Program.
Settling down to finalists.
That we're just doing sort of final characterization on the on the profile.
And then.
Assuming that all goes well.
Again, we're targeting Q4 as.
Is the timing for that candidate selection final selection.
Great. Thanks, I'll hop back in queue.
Okay.
Thank you.
Yes.
We also have a question from.
Nick <unk> with Leerink partners. Your line is open.
Hi, everybody. Good afternoon. This is Nick <unk> on the line for Roanna Ruiz. Thanks for taking our questions maybe first off on your RSV program.
Which 323 doses are you planning to evaluate in the upcoming challenge study I don't know if you have mentioned that and maybe also I guess, what learnings from the development of 93, eight so far could you apply that to possible future development of 300 to 300.
Are you planning to go after similar patient populations for three two to three years could you explore other populations as well.
Yes so.
We haven't disclosed the.
The final doses for that study, we're likely to do that in connection with the announcement of the initiation of the study so stay tuned for that again.
We're aiming for early early Q4.
But suffice it to say there'll be doses within the ranges that we've studied were really trying to adjust to figure out what optimal.
Doses for various exposures that we want to try to hit and look at the product profile overall.
And then.
With regards to 93 eight I mean, we've learned a lot about RSV through the use of 93 eight and.
I can only imagine that we will have a more targeted expedient pathway for <unk> three based on our learnings.
Whether it was what we learned in the standard risk patient population, which is.
That patient population doesn't need a drug.
And then through through the recruitment.
Of our <unk>.
<unk> high risk patient populations.
It's very interesting teachings each of those patient populations that you can only sort of figure out once you get in to them.
And.
We've learned a lot along the way with.
With 93 eight.
So.
Exactly the <unk>.
The trial after.
The human Challenge study.
Something that we're thinking about very diligently right now, but not ready to speak to today.
Got it and also are you are you planning to pursue or evaluate 323 in similar patient populations or would you explore.
Other types of patients as well.
Well those are the three high risk patient populations.
It's probably the largest patient population from a market perspective.
High risk adults.
And.
Immune compromised.
<unk> of different flavors, I mean, we've chosen from immune compromised.
At least in.
RSV Tx.
With 93 eight.
Zeroed in on hematopoietic stem cell transplant, but theres other immune patient populations immune suppressed patient populations that one.
It could also consider but.
But any way you want to be in a high risk patient population of one flavor or another if you really want to.
To get it over the finish line.
Helpful. Thanks, Jeff.
Youre welcome.
Thank you and I'm showing no further questions at this time I would like to turn the call back over to Jennifer Viera for any closing remarks.
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 us at the office. Thanks, So much and have a good night.
Yes.
This concludes today's conference call. Thank you for participating you may now disconnect.
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Dan.
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