Q4 2022 Arbutus Biopharma Corp Earnings Call
Good day, and thank you for standing by and welcome to the arbitrage Biopharma Corporation fourth quarter and year end 2022 financial results and corporate update conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session you'll need to press star one.
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Please be advised today's conference is being recorded I would now like to hand, the conference over to your speaker today. Mr. Reilley. Please go ahead.
Thank you, Kevin and good morning, everyone and thank you for joining <unk> fourth quarter and year end 2022 financial results and corporate update call.
Joining me today from <unk> Executive team are Bill Collier, President and Chief Executive Officer, David Hastings, Chief Financial Officer, and Dr. Mike Sofia, Chief Scientific Officer.
Bill will begin with a corporate update followed by Dr. Sofia will provide an overview of our newly nominated Corona virus compound <unk> three for three days.
Dave Hastings will then provide a review of the company's fourth quarter and year end 2022 financial results.
After our prepared remarks, we will open the call for Q&A.
Before we begin I'd like to remind you that some of the statements made during the call. Today are forward statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our annual report on Form 10-K to be filed later today and from time.
At the time and our other documents filed with the SEC.
With that I'll turn the call over to Bill Collier Bill.
Thank you Lisa good morning, everyone and thank you for joining US today. We appreciate your continued interest.
And supportive Arbutus biopharma.
Morning, We issued a press release with our fourth quarter and year end 2022 financials as well as an update on the significant progress we made last year in advancing our proprietary compounds.
Moving us closer to our goals of potentially achieving a functional cure for chronic HBV as.
As well as a novel and superior treatment for Corona.
We also highlighted our anticipated milestones for 2023, which include announcing a b seven to nine data from our two ongoing phase II combination trials.
And additional off treatment data from our phase <unk> clinical trial.
We also intend to initiate in 2023, three phase one clinical trials with our early stage compounds, namely <unk>, one oral PDL one inhibitor.
Maybe 161 oral RNA destabilizer and a be three for three on newly nominated MSP five main protease inhibitor in development for coronavirus infection.
Suffice it to say 2023 will be a busy year for us with potentially four compounds in the clinic by the end of the year.
With respect to our mission to achieve a functional cure for patients with chronic HBV. We believe it is necessary to suppress HBV DNA reduce surface antigen.
Boost the immune system.
Data that we generated last year from our phase <unk> clinical trial tells us that <unk> can potentially achieve all three of these goals.
This <unk> 79 up from other RNA therapeutics in development.
First <unk>.
As shown reawakening of HBV specific immunity as well as a decrease in exhausted T cells in some patients.
In addition, a small subset of patients who met eligibility requirements to discontinue all HBV therapies following <unk> treatment with <unk>.
To control the HBV biomarkers while off.
<unk> treatment.
Surface antigen levels in those patients remained well below pre trial levels further.
Furthermore, the HBV DNA remains low suggesting establishment of host immune control.
Now these data reinforce our belief that AB 729 is one of the most evolved RNA therapeutics in development and that it has the potential to be a cornerstone therapeutic in the treatment regimen for chronic HBV.
Each leads me to our two ongoing phase II clinical trials with AB seven to nine one in combination with interferon and one in combination with <unk> therapeutic vaccine <unk> 300.
At the end of 2022, we completed enrollment and announced preliminary data from the lead in phase of AEP 72 nine to one.
Phase Iia clinical trial with <unk> in combination with <unk> ongoing nucleoside analogue therapy and short courses of interferon.
The first 15 patients who reached week 16 of treatment after receiving two doses of <unk> 72, nine on day, one and we Kate plus Nuc therapy showed a mean surface antigen decline of one five logs, which is comparable to the decline observed at the same time point.
<unk> phase one clinical trial.
These preliminary data further validate <unk> 17 on capacity to reduce surface antigen.
As patients complete the leading site they are being randomized to receive interferon plus nuc therapy, plus or minus additional seven to nine doses for either 12 or 24 weeks.
Expect to have preliminary data from some of these patients who have received into payroll in the first half of 2020.
Our second phase III clinical trial, a b seven to 922, which is evaluating <unk> in nuc therapy, and <unk> hundred or placebo.
Being expanded to include an additional <unk> with low dose and the volume at which is a PD one monoclonal antibody inhibitor. That's approved for a number of types of cancer under the brand name Opdivo.
We are adding the volume up more commonly known as neither to determine if the addition of <unk> to the <unk> 300 combination will further stimulate immune mediated reduction of surface antigen. After the initial treatment with <unk>.
This amendment is currently under regulatory review.
On regulatory approval, we intend to enroll 20 patients on ongoing nuc therapy.
You will receive 60 milligrams every eight weeks for 24 weeks.
Road by <unk>, 300, plus a low dose of polymer.
The levo dose that we will use its 110th the dose approved for oncology indications.
Which we believe to be a safe yet applications.
Patients will remain on the nuc therapy during the 48 weeks of dosing with <unk> 300 and neither.
Like all our trials, we will follow patients for 24 to 48 weeks after completion of the treatment period.
As a reminder, dosing in this amended portion of the trial is expected to commence in the first half 2023.
Preliminary data from the original portion of the clinical trial.
Those patients who received 17, one nuc and <unk> hundred or placebo is expected in the second half of 2023.
To round out our HBV assets last year with nominated and conducted R&D, enabling studies with <unk> 101 is our oral PDL one inhibitor.
And with AB 161 is our oral RNA destabilizer.
Both of these programs could play a role in developing a proprietary oral combination therapy to provide a functional cure for patients with chronic HBV.
We are on track to initiate phase one clinical trials with each of these compounds and we expect to report initial data this year.
We will share more details with each of these trials commences.
Finally, as Dave will reiterate in a moment, we are in a strong financial position with.
With cash runway into Q4 of 2024.
I'll now ask Mike Sofia to review, our progress and the coronavirus.
Over to you Mike.
Thanks, Bill good morning, everyone.
For the past year <unk> research team is relentlessly focused on identifying and developing new anti viral small molecules.
Pre COVID-19, and future coronavirus outbreaks.
Many question, whether there would be a need for new or more.
A lot of therapeutics for quarter boxes, and I believe we can also meet exist as of ours continues to mutate spread and re impact.
Our strategy focuses on targeting two with central enzymes critical for bar replication and that are highly conserved across all known Corona viruses.
Targets are the Sars koby to NSP five main protease also known as <unk> and NSP 12 borrower polymerase.
We plan to identify compounds that target each of these and a central enzymes developed those compounds and ultimately combine them to pursue an optimized treatment regimen that is safe effective convenient enable to address current and future corn of our streams.
Through our research efforts, we have discovered a nominated AB 343 and.
<unk> inhibitor.
Our lead oral corner virus drug candidate.
We selected AB 340, <unk> based on its preclinical activity safety profile and the potential for convenient dosing.
From an activity standpoint, maybe 343 is highly potent with a nicely 50 against the enzyme and single digit nanometer, but has equal potency against all known Sars Covid two variants and robust activity.
<unk> known and pro resistant variants.
With respect to safety $83 three is highly selective for coronavirus and pro versus tumor proteases.
It also has a clean broad cellular toxicity profile.
Assessment profile.
These characteristics support.
<unk> potential for unwanted side effects, thus further supporting candidate nomination and justification for progression into development.
Equally important to developing a drug that is safe and efficacious this and ensure that the drug is convenient for patients and physicians.
Based on the preclinical PK data <unk> III <unk> III does not require enhancing with return of your boosting.
This could lead to decreased pill burden and reduced potential for drug drug interactions seem with the return of your boosted regimens.
I am impressed with AB three preclinical profile and excited to move it forward into Ivy, enabling studies with the intent of initiating a phase one clinical trial in the second half of this year.
As I mentioned in my opening remarks, we are targeting two with central enzymes. The second one being NSP 12 viral polymerase or.
Our research team is closing in on its efforts to identify the lead candidate <unk> into IND, enabling studies in the second half of this year.
We will provide an update on that compound has been identified nominated.
I will now turn the call over to Dave Hastings for a brief financial update Dave.
Thanks, Mike.
Good morning, everybody.
As I've mentioned in the past, our key financial metrics, our cash and financial runway.
Our cash cash equivalents and investments were approximately $184 million.
As of December 31, 2022, as compared to approximately $191 million as of December 31, 2021.
Yes.
During the year ended December 31 2022.
Company received a $40 million upfront payment from <unk> pharmaceutical company related to <unk>.
Technology transfer and license agreement for AB 709 in greater China <unk>.
$15 million of gross proceeds from <unk> equity investment in the company.
And approximately 20 million in net proceeds from the issuance of common shares under our <unk> aftermarket offering program.
These cash inflows were partially offset by approximately $79 million of cash used in operations.
The company expects a net cash burn of net cash burn of between $95 million to $100 million in 2023 and believes its cash runway will be sufficient to fund operations into the fourth quarter of 2024.
Additionally.
We were pleased to see that owners, who we sold our primary royalty interest on Patrick two now has earned $18 9 million in cumulative royalties now as a REIT.
Reminder, once Omar is collect $30 million on Patrick royalties.
That entitlement will revert back to us.
After that reversion, our royalty rate is tiered with a top tier being slightly over 3% for annual net sales greater than $500 million.
So in closing we are well positioned financially to advance our mission to develop a functional cure for HBV and a treatment for COVID-19, and potential future coronavirus outbreaks.
With that I'll turn the call back to Bill.
Thanks, Dave.
For our Q&A session I want to just quickly remind everyone of the key milestones that we anticipate for 2023.
And they are as follows we plan to report initial data from the phase Iia clinical trial, combining <unk> nuc therapy and <unk> 300.
In the second half of 2023.
Thank you dose the first patient with <unk> and the clinical trial amendments that combines a 79 PTP 300 plus NEVA.
We also plan to announce preliminary interferon data from patients in the seven to nine to a one clinical trial.
<unk> 72, nine plus therapy plus into payroll.
We plan to announce additional off treatment data from seven to nine phase one b trial.
We plan on reporting initial data from the healthy volunteer single dose portions of our phase one clinical trials for AG 101, and <unk> 106, one.
Finally, we plan to initiate a phase one clinical trial for <unk> three for three <unk> coronavirus clinical candidate.
And we look forward to providing you with updates as we progress our clinical development and achieved these milestones.
Operator, we're now ready for our Q&A session over to you.
Hello, Ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, one moment for our first question.
Our first question comes from Dennis thing with Jefferies. Your line is open.
Hi.
Sure.
Thanks for the question.
Two for me.
In terms of.
Your corporate strategy. This year, maybe comment on what your priorities are and how to balance your pipeline versus.
Finding some BD opportunities with with their broad pipeline and then my second question is just around when you talk with potential partners in this space.
B J.
Generally speaking what level of.
Clinical risk do you think partners would be comfortable with.
And what do you think they would want to see before potentially advancing discussions with with you. Thank you.
Thank you Dennis let me take the first part of the question and then I think Mike Mack is on the line.
And he can take the second piece.
We believe actually we've made a number of adjustments in our strategy in the last year or so in order to focus in on HBV and Corona virus.
Indeed mix that includes making some some pretty tough decisions.
So youll notice today, we've said nothing about capsid inhibitors going forward.
So that's an illustration that we believe we have a very good compound in 79.
We're confident in moving 161, and 101 into the clinic, which could round out a very nice HBV portfolio.
As Mike just described.
Spending some of our resources on coronavirus, we believe is still very relevant given the ongoing.
Epidemic pandemic around the world.
And we've been able to do all of that whilst.
Tending all cash runway out to the end of 2024.
So we feel like we have made some tough choices.
And prioritized appropriately.
But still maintaining.
A real tight focus on our vision.
In trying to find a functional cure for HBV and.
And effective treatment for coronavirus.
Mike you're kind of taking the second part of the question.
I am so this was the one is related to.
What level of clinical risk is relevant.
Correct Bill.
Okay.
Okay.
Yes, Dennis Thanks for the question.
Sure.
As we've discussed in the past we have conversations with everybody in the field frequently.
At all.
No.
Any conference that we're at we're British people.
Our reach out to people all the time.
In regards to.
Fee.
The BD work that needs to be done so I'm always having conversations with people as far as as far as what level of clinical risk as is.
It's sort of there.
<unk> guideline.
They don't really tell me that.
I think it's variable depending on who you are speaking to.
What are you speaking to a large company or a small company.
And.
I think we just have to let the data evolve and see.
Yes, those conversations progress.
But we will continue to have those conversations.
Got it thank you.
Thank you Dennis.
One moment for our next question.
Yeah.
Our next question comes from Brian <unk> with Baird. Your line is open.
Yeah.
Hey, Good morning, guys. This is Charlie on for Brian .
So I was curious if theres anything we can look for beyond safety to get a good grasp on potential activity for either the oral PD lone or the RNA destabilizer.
As well as <unk>.
Looking at seven to nine.
With one of the patients becoming eligible to restart nuc therapy.
Just curious.
But what kind of proportion would you be looking here for the remaining patients in terms of defining success for you guys. Thank you.
Yes, Okay. Good question and maybe Microsoft here would you like to talk about 106, one of them one on one I'll come back on.
Yes.
Sure.
Thanks, Robert for the question. So so when we look at they are oral PDL, one inhibitor <unk> zero one.
Obviously.
We're looking at safety is our first.
Readout in the phase one studies, but we can also actually gain some insight on how this molecule is working and whether we anticipate efficacy.
We're looking at.
So we have several ability is to look at target engagement and target occupancy.
So from those studies, we'll be able to see whether this molecule is actually <unk>.
Gauging the target.
And producing some some kind of target relevant biological readout from the immunology side. So so that will give us some early hints on.
Whether this molecule has the potential to show HBV clinical efficacy as we progress into phase <unk> studies. So we will get that in the <unk> portion of the study.
Pretty pretty early and so will be able to say something about that by the end of the year.
When you look at maybe 106, one RNA destabilizer oral compound.
Clearly this field has has struggled with with safety safety is going to be a big part of.
How we assess this very early on.
As Ive always mentioned, we've done a very extensive preclinical safety assessment based on.
Our previous knowledge that we gained on AB 450 <unk> in.
In the peripheral neuropathy studies and so we've done 60 day two species toxicology studies I mean assume 90 day two pieces two species toxicology studies to reaffirm our belief that this molecule has a safety profile that we feel confident in going forward in the clinic, but that early obviously.
Phase one studies, where we'll be looking at safety pretty clearly in and.
Paying clear attention to some of the some of the signals for further peripheral neuropathy are going to be important to us.
Once that once that is done then obviously, we will run right into a phase <unk> study, where we will be capturing that efficacy aspect of it the biomarkers specifically looking there.
At S antigen reduction.
And HBV DNA reductions in those parts of the <unk> study.
Alright, and then on the seven to nine follow up of these nine patients who are now possible clarity.
I just wanted to clarify we now have seven patients remaining for follow up.
But I wanted to.
Just clarify, but actually so far only one patient has met the.
Clinical criteria to meet stops therapy.
There was one other patient who experienced what looked like some kind of increase in HBV DNA, but before that patient.
He stopped criteria.
<unk> physician.
The patient decided to stop therapy other than nine when you have one thats met the predefined.
Coal criteria for restarting therapy. So we remain really intrigued and interested in this data we think it is well worthwhile following up we have.
Some interest obviously from <unk>.
Physicians and Kols and continuing to track these patients.
I should point out that many of these patients now multiple weeks into.
Being off of therapy.
And so I think as we've alluded to we will track these patients and continue to report data as we progress through 2023.
Wonderful thank you.
One moment for Charleston.
Yes.
Yes.
Our next question comes from Thomas Yip with H C. Wainwright Your line is open.
Hi, Good morning, everyone Thomas asking a couple questions for Ed.
So first a follow up.
Right on.
Of the seven patients that remain on treatment and the old one study.
Can you tell us what is the <unk>.
Range.
How many weeks these patients have gone off treatment.
How frequently shoe expect updates.
Year from those patients.
Yes, so on the updates we've said, we'll provide an update in.
In the first half of the year.
And I'll just say as we continued to progress during the year as Dave said in used and will provide further updates.
I'm actually having to work from home today, you can tell I have a.
Horrendous head cold.
I actually don't have the data for the number of weeks of therapy in front of me. So I was just wondering if there is.
Anyone else on the call it has that information.
I don't know where the mic macro Microsoft mostly just looking back on the deck here one.
One second bill so yes.
Patients.
Have been off therapy as of the last data update at least patients had been off therapy anywhere from sort of lets see.
To 20 call it call it roughly 20 weeks to 244 weeks.
Or more that's right. So as of the last day to update remember so patients. Obviously, you can continue to track that forward and get a sense for where patients.
Yes.
Slide 13 actually in the corporate deck, which you can see the data from the nine patients and this was what we reported in December last year.
So Mike has given you the range of weeks and then we can add on I guess two more weeks since the December update last year.
Thank you Thomas right, Yes, yes, you alluded to seven patients a month in mind so.
Sure.
Couple of months.
More than 40.
Forward.
Yes.
Okay.
And then as you as we continue to see it as a premium data with more patients.
What do you expect some findings that you continue to correct that.
That impacts the ongoing phase two combination studies.
You mean, what data could we expect from these remaining seven patients.
Or more specifically what.
What kind of findings.
You expect from these patients that could potentially.
Change or alter or any.
The phase two combination studies that are either ongoing or near cohorts, yes, okay understood.
Obviously, we want to continue to attract them.
I hope not.
Not too many more.
The criteria to restart treatment, but that's one potential outcome.
Another potential outcome as we potentially get a few who do actually go on detectable.
Just have two to track.
Obviously, we'll report if that does happen.
And then the other at Tommy that actually.
They kind of continue to stay as they are.
Which is low levels of HBV DNA low levels of surface antigen not meeting the criteria to restart treatment, but not undetectable.
Undetectable.
Which I think would be a demonstration, but actually treatment with <unk> and a nuc.
Does actually get these patients to a position.
Whether they're able to come off therapy might also indicate that.
The ultimate combination of fund.
<unk> share would be 17 on the new and then a third agent.
Designed to further boost the immune system, which is why PD Lone program comes in.
So that I think would be the.
Interesting information and then obviously, we're looking for the same thing in our Phase Iia study is whether or not the addition of interferon and all.
<unk> hundred plus 12 months NEVA results and further.
S antigen reductions than 17 million alone and then obviously in the follow up period will be looking to see how these patients respond when the off trade.
Got it. Thank you so much I, perhaps one final question from us.
Speaking.
300 combination study.
What type of preliminary data should you expect to be announced in the second half of this.
This year from this study.
Yes, I think the best way to think about that.
Corporate deck, we've kind of laid out the trial designs for both the <unk> 300 study.
So we're going to be in the phase.
The patients have received <unk> 300.
Or the placebo.
And therefore, that's the type of data that we will be sharing later this year.
We won't be.
April just because of the length of the study.
Report end of treatment days for a follow up data so it's going to be somewhere if you look at slide 18.
We're in that kind of dark red.
Phase where patients are receiving <unk> 300 or placebo.
Okay got it thank.
Thank you so much again for taking my questions.
Good morning.
One moment for our next question.
Our next question comes from Keith Mackey with Chardan. Your line is open.
Yes, a couple of questions.
For the one.
Bob.
Todd.
Okay. We are unable to hear you.
Yes, sorry.
Can you hear me now.
Yes, a little better.
Okay.
The one patient who was off treatment and then met the criteria to restart how long were they able to stay on treatment.
Sure.
Uh huh.
Can I get back to you on that K I don't know that I have.
That information immediately at my fingertips.
Okay.
No no.
Is that available if you'd mind.
Okay.
One patient that required restart because of the protocol defined criteria.
Discontinued follow up week 36 after after 36 weeks after they stopped all therapies.
Yes.
Yes, thanks, Mike equivalent slot.
13 in the deck.
<unk> cut the bottom.
Thank you.
Okay and then.
Mike.
Pro as you take that into the clinic.
Once you get the.
Safety.
And want to evaluate it.
Patients who may have the virus.
What might that study look like what would be maybe.
Targeted course of therapy, it's going to be like a five day like tax a bit or maybe give us some thoughts about that.
Yes.
Yeah. Thanks, Vijay Okay. So I think.
The.
We haven't really.
Sort of communicated with our clinical development plan is going to be but you can imagine based on what what some of our competitors have done in the field.
We would be looking at potentially readouts that we would look at viral load decline they could look at.
Look at reduced hospitalization one of the things that we're really quite interested in is as we go forward is.
This molecule or ultimately our combinations produce.
The effect on reduction in symptomology or potentially pre exposure prophylaxis. So so so those are the kinds of things that we're targeting in and sort of mapping out our clinical development plan.
And.
Eager to get those started as soon as possible.
Okay.
And then.
Once you have the second compound ready to go into the clinic.
How how soon would you evaluate it as a combo therapy at least in terms of safety.
Well I mean, we could do some preclinical assessments will look at combination safety.
Yeah.
And we do a lot of that sort of in let's say in the preclinical.
Environment.
Once we once we get.
Our second molecule.
Nominated to move through IND, enabling studies, we will do our phase one <unk>.
With the single agent and we added certainly based on.
Previous.
Developments in AI and <unk> will have to show that it works and is safe by itself and then as rapidly as we possibly can assuming we all those ducks lined up now we will get into combination but.
Right now we're looking at hopefully a fairly short early clinical development program because of the short duration of therapy that you need to show some kind of anti viral effect.
Hopefully, we will accelerate our ability to get into combination.
Okay and then just the final question on the litigation with <unk>.
Darren.
Any update you can provide as far as a next step in that process.
Thank you Kay.
Unfortunately not.
We're going to stick to a policy that we've had since we filed that.
Case last year.
Just don't comment on the ongoing twist some stance the case so.
No you didn't see any updates in our press release, our prepared remarks.
Although frustrating for you guys.
Which I understand.
That one's a no comment.
Okay very good thanks.
Thank you so much.
One moment for our next question.
Our last question comes from Roy Buchanan with JMP Securities. Your line is open.
Hey, Thanks for taking my questions.
A few for Covid first I guess, so 343 looks.
It looks very potent do you anticipate once daily oral dosing.
When do you think we might see that preclinical data first presented for that and then the IC 50, presumably that's in vitro and not sell base can you give us any details on what system that was thanks.
Alright, well.
Yeah, our PK so we have.
One presentation, that's going to be at <unk>. This year in a couple of weeks.
We will highlight.
The entire in vitro profile of the molecule itself.
I mean, we have.
Anticipate submitting a couple of abstracts.
Other meetings coming up in the very near future too.
Also share.
Preclinical data that we have.
On the molecule so hopefully some of that will be rolling out.
Shortly for everyone to see.
And.
Let's see.
Exciting molecule, we have maybe 343.
Okay, Great and then any comments on the once daily dosing.
I can say, our PK looks very good.
We in multiple species, where you just have to see once we get into the clinic what the.
Dosing frequency you needs to be but right now we're pretty optimistic.
Okay, Great and then on the 79.
Can you just remind us the criteria for restarting the nukes for that patient that had to restart what's the criteria.
Good question.
I can follow up later, if it's not.
No I think that one is not on the slide Thats, what I was looking at so we'll follow up with you.
Okay.
Okay, Great and then I had.
So it looks like gsk's limiting and that would be.
Phase III the <unk>.
Primary endpoints.
Baseline S antigen below a thousand it looks like maybe that's 15% to 20% of the population in their phase III is that consistent with kind of your view of the overall THB population and then it looks like pretty much all the patients that you have off therapy, except maybe one.
We're above 1000 is that right.
Am I looking at that correctly. Thanks.
Good question I don't know that I can comment on the GSK trial.
But the.
Nine patients. So we had discontinue I think had.
All sorts of historic.
Starting S antigen levels we.
We can get that information for you right.
Yes, just looking at the <unk> presentation. It looks like maybe one is below a 1000, but the rest.
It looks like they're above okay.
And then I guess just for the interferon combo readout. This half I know you guys have been asked this before just what are we.
Key points that we should be looking out for for that data. Thanks.
Yes, so I mean.
As I said in my prepared remarks, I mean, I think the key thing that we.
Would want to see is a.
Further reduction in S antigen.
So you treat with <unk> 79, and then.
Potentially.
After you add in these other agents a further reduction in S antigen.
Which could be reflective of.
Immune response.
But I will add the caveat that.
We've seen in other studies doesn't necessarily happen immediately with interferon and such.
Times It takes a while sometimes yourself to the interferon therapy has stopped.
So.
We'll have to see how our data pans out on.
We'll make the appropriate commentary when we when.
When we do that update.
Okay, great. Thank you.
Ladies and gentlemen.
The Q&A portion of today's call I'd like to turn the call back over to Bill for any closing remarks.
Well, thank you very much.
For joining us this morning, I'm also thankful my voice managed to hold up.
We do appreciate your continued interest abuses.
We especially look forward to providing you with further updates.
As we progressed the development of our HPV and coronavirus assets.
Thanks, again for joining and operator that concludes our call.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
The conference will begin shortly to raise and lower Johan during Q&A you can dial one one.
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Good day, and thank you for standing by and welcome to the RP, Just Biopharma Corporation fourth quarter and year end 2022 financial results and corporate update conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session you'll need to press star one on your telephone you will then hear an automated messages.
And your hand is raised to withdraw your question. Please press star one again.
Please be advised today's conference is being recorded I would now like to hand, the conference over to your speaker today, Lisa cap rally. Please go ahead.
Thank you, Kevin and good morning, everyone and thank you for joining <unk> fourth quarter and year end 2022 financial results and corporate update call. Joining me today from <unk> Executive team are Bill Collier, President and Chief Executive Officer, David Hastings, Chief Financial Officer.
And Dr. Mike Sofia, Chief Scientific Officer.
Bill will begin with a corporate update followed by Dr. Sofia will provide an overview of our newly nominated Corona virus compound AB.
Fourth right Dave.
Dave Hastings will then provide a review of the company's fourth quarter and year end 2022 financial results.
After our prepared remarks, we will open the call for Q&A.
Before we begin I would like to remind you that some of the statements made during the call today are forward.
<unk>.
Subject to a number of risks and uncertainties that may cause our actual results could differ materially including those described in our annual report on Form 10-K to be filed later today and from time to time in our other documents filed with the SEC.
With that I'll turn the call over to Bill Collier Bill.
Thank you Lisa good morning, everyone and thank you for joining US today. We appreciate your continued interest and support of Arbutus Biopharma.
Morning, We issued a press release with our fourth quarter and year end 2022 financials as well as an update on the significant progress we made last year in advancing our proprietary compounds moving us closer to our goals of potentially achieving a functional cure for chronic HBV as.
As well as a novel and superior treatment for Corona.
We also highlighted our anticipated milestones for 2023, which include announcing a $17 nine data from our two ongoing phase II combination trials.
And additional off treatment data from our phase <unk> clinical trial.
We also intend to initiate in 2023, three phase one clinical trials with our early stage compounds, namely <unk> 101, oral PDL one inhibitor.
Maybe 161, our oral RNA Destabilizer and AB three for three on newly nominated NSP five main protease inhibitor in development for Corona virus infection.
Suffice it to say 2023 will be a busy year for us with potentially four compounds in the clinic by the end of the year.
With respect to our mission to achieve a functional cure for patients with chronic HBV. We believe it is necessary to suppress HBV DNA reduce surface antigen.
Please the immune system.
Data that we generated last year from our phase <unk> clinical trial tells us that <unk> can potentially achieve all three of these goals.
This <unk> 79 up from other RNA therapeutics in development.
First <unk>.
As shown reawakening of HBV specific immunity as well as a decrease in exhausted T cells in some patients.
In addition, a small subset of patients who met eligibility requirements to discontinue all HBV therapies following <unk> treatment with <unk>.
To control the HBV biomarkers, while off treatment.
Surface antigen levels in those patients remained well below pre trial levels fell.
Furthermore, the HBV DNA remains low suggesting establishment of host immune control.
Now these data reinforce our belief that <unk> is one of the most advanced RNA therapeutics in development and that it has the potential to be a cornerstone therapeutic in the treatment regimen for chronic HBV.
This leads me to our two ongoing phase Iia clinical trials with AB seven to nine one in combination with interferon and one in combination with <unk> therapeutic vaccine <unk> 300.
At the end of 2022, we completed enrollment and then announce preliminary data from the lead in phase of AEP 72 nine to one.
Phase Iia clinical trial with <unk> in combination with <unk> ongoing nucleoside analogue therapy and short courses of interferon.
The first 15 patients who reached week 16 of treatment after receiving two doses of AB seven to nine on day, one and we Kate plus nuc therapy showed a mean surface antigen decline of one five logs, which is comparable to the decline observed at the same time point.
<unk> phase <unk> clinical trial.
These preliminary data further validate <unk> 17 on capacity to reduce surface onto Jim.
As patients complete the leading site they are being randomized to receive interferon plus nuc therapy, plus online as additional seven to nine doses.
12, or 24 weeks and.
And we expect to have preliminary data from some of these patients who have received into payroll in the first half of 2020 story.
Our second phase III clinical trial.
$17 92, which is evaluating <unk>, two nine nuc therapy, and <unk> hundred or placebo.
Is being expanded to include an additional <unk> with low dose and the volume that which is a PD one monoclonal antibody inhibitor. That's approved for a number of types of cancer under the brand name Opdivo.
We are adding the volume up more commonly known as <unk> to determine if the addition of <unk> to the <unk> 300 combination will further stimulate immune mediated reduction of surface antigen. After the initial treatment with seven to nine.
This amendment is currently under regulatory review.
Regulatory approval, we intend to enroll 20 patients on ongoing nuc therapy.
You will receive 60 milligrams seventy-nine every eight weeks 24 weeks.
Followed by <unk>, 300, plus a low dose and polymer.
Neither dose, but we will use is 110th the dose approved for oncology indications, which we believe to be a safe yet efficacious.
Patients will remain on the nuc therapy during the 48 weeks of dosing with <unk> 300 and neither.
Like all our trials, we will follow patients for 24 to 48 weeks after completion of the treatment period.
As a reminder, dosing in this amended portion of the trial is expected to commence in the first half of 2023.
Preliminary data from the original portion of the clinical trial.
It is those patients who received seven to nine new <unk> hundred or placebo is expected in the second half of 2023.
To round out our HBV assets last year, we nominated and conducted R&D, enabling studies with <unk> 101 is the oral PDL one inhibitor.
On with AB 161.
<unk> RNA destabilizer.
Both of these programs could play a role in developing a proprietary all oral combination therapy to provide a functional cure for patients with chronic HBV.
We are on track to initiate phase one clinical trials with each of these compounds and we expect to report initial data this year.
We'll share more details when each of these trials commences.
Finally, as Dave will reiterate in a moment, we are in a strong financial position with.
With cash runway into Q4 of 2024.
I'll now ask Mike Sofia to review our progress in the coronavirus.
Over to you Mike.
Thanks, Bill good morning, everyone.
For the past year. The Arbutus research team is relentlessly focused on identifying and developing new antiviral small molecules.
COVID-19, and future coronavirus outbreaks.
Many question, whether there would be a need for new or more.
<unk> therapeutics four corner boxes, and I believe we can all say that the need exists as the virus continues to mutate spread and re impact.
Our strategy focuses on targeting two with central enzymes critical for Barbara application and that are highly conserved across all know corona viruses.
These two targets are the Sars koby to NSP five main protease also known as <unk> in the NSP 12 borrow polymerize.
We plan to identify compounds that target each of these and a central enzymes developed those compounds and ultimately combine them to pursue an optimized treatment regimen that is safe effective convenient enable to address current and future credit of our streams.
Through our research efforts, we have discovered denominated AB 343, and <unk> inhibitor.
As our lead oral corner buyers drug candidate.
We selected AB 340, <unk> based on its preclinical activity safety profile and the potential for convenient dosing.
From an activity standpoint, <unk> is highly potent with a nice 50 against the enzyme and single digit in animal work.
Potency against all known <unk> koby to variance <unk>.
<unk> activity against.
Against known MRO resistant variants.
With respect to safety AB 343 is highly selective for coronavirus and pro versus tumor proteases.
It also has a clean broad cellular toxicity profile and off target assessment profile.
These characteristics support <unk>.
The potential for unwanted side effects, thus further supporting candidate nomination and justification for progression into development.
Equally important to developing a drug that is safe and efficacious and ensure that the drug is convenient for patients and physicians.
Based on our preclinical PK data AB three for three does not require enhancing with retirement are boosting.
This could lead to decreased pill burden and reduced potential for drug drug interactions theme with the retirement of euro boosted regimens.
I am impressed with $83 three preclinical profile and excited to move it forward into IND, enabling studies with the intent of initiating a phase one clinical trial in the second half of this year.
As I mentioned in my opening remarks, we are targeting two with central enzymes. The second one being NSP 12, our preliminaries. Our research team is closing in on its efforts to identified a lead candidate to reconvert take into IND, enabling studies in the second half of this year.
We will provide an update on that compound has been identified nominated.
I will now turn the call over to Dave Hastings for a brief financial update Dave.
Thanks, Mike.
Everybody.
As I've mentioned in the past, our key financial metrics, our cash and financial runway.
Our cash cash equivalents and investments were approximately $184 million as of December 31, 2022, as compared to approximately $191 million as of December 31 2021.
Okay.
During the year ended December 31 2022.
The company received a $40 million upfront payment from <unk> pharmaceutical company related to.
The technology transfer and license agreement for AB 709 in greater China <unk>.
$15 million of gross proceeds from <unk> equity investment in the company.
And approximately $20 million of net proceeds from the issuance of common shares under our <unk> aftermarket offering program.
These cash inflows were partially offset by approximately $79 million of cash used in operations.
The company expects a net cash burn of net cash burn of between $95 million to $100 million in 2023 and believes its cash runway will be sufficient to fund operations into the fourth quarter of 2024.
Additionally.
We were pleased to see that owners, who we sold our primary royalty interest on Patrick two now has earned $18 9 million in cumulative royalties.
Reminder, once Omar is collect $30 million in on Patrick royalties that entitlement will revert back to us.
After that reversion a royalty rate is tiered with a top tier being slightly over 3% for annual net sales greater than $500 million.
So in closing we are well positioned financially to advance our mission to develop a functional cure for HBV and a treatment for COVID-19, and potential future coronavirus outbreaks.
Now I'll turn the call back to Bill.
Alright, Thanks, Dave before our Q&A session I want to just quickly remind everyone of the key milestones that we anticipate for 2023.
They are as follows we plan to report initial data from the phase Iia clinical trial, combining <unk> nuc therapy, and <unk> 300 in the second half of 2023. Thank.
Thank you dose the first patient with <unk> and the clinical trial amendments that combines AP <unk> PTP 300, plus an Eva.
We also plan to announce preliminary interferon data from patients in the <unk> <unk> to a one clinical trial with <unk>.
<unk> 72, nine plus therapy plus into payroll.
We plan to announce additional off treatment data from seven to nine phase one b trial.
We plan on reporting initial data from the healthy volunteer single dose portions of our phase one clinical trials for AG 101, and AB 161.
Finally, we plan to initiate a phase one clinical trial for <unk> three for three and pro coronavirus clinical candidates.
And we look forward to providing you with updates as we progress our clinical development and achieved these milestones.
Operator, we're now ready for our Q&A session over to you.
Ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again, one moment for our first question.
Our first question comes from Dennis thing with Jefferies. Your line is open.
Hi.
Thanks Kurt.
Thanks for the question.
Two for me.
In terms of.
Your corporate strategy this year, maybe comment on what your priorities are.
And how to balance your pipeline burst.
Finding some BD opportunities with with their broad pipeline and then my second question is just around when.
Can you talk with potential partners in that space.
<unk>.
Generally speaking what level of <unk>.
Clinical risk do you think.
Partners would be comfortable with.
And what do you think they would want to see before potentially advancing discussions with with you.
Thank you.
Thank you Dennis let me take the first part of the question and then I think Mike Mack is on the line.
And he can take the second piece.
We believe actually we've made a number of adjustments in our strategy in the last year or so in order to focus in on HBV and Corona virus.
Indeed.
That includes making some some pretty tough decisions.
So youll notice today, we said nothing about capsid inhibitors going forward.
So that's an illustration that we believe we have a very good compounding 79.
We're confident in moving 161, and 101 into the clinic, which could ramp up a very nice HBV portfolio.
As Mike just described.
Spending some of our resources on coronavirus, we believe is still very relevant given the ongoing.
Epidemic pandemic around the world.
And we've been able to do all of that whilst.
Tending all cash runway out to the end of 2024.
So we feel like we have made some some tough choices.
And prioritized appropriately.
But still maintaining a real tight focus on our vision.
In trying to find a functional cure for HBV and an effective treatment for coronavirus.
Yeah.
Mike you're kind of taking the second part of the question.
I am so this was the one that is related to.
What level of clinical risk is relevant.
Correct Bill.
Okay.
Okay.
Yes, Dennis Thanks for the question.
Sure.
As we've discussed in the past we have conversations with everybody in the field frequently.
At all.
Any conference that we're at we're British people are.
I reach out to people all the time.
In regards to.
Fee.
The BD work that needs to be done so I'm always having conversations with people as far as as far as what level of clinical risk as is.
It's sort of there.
<unk> guideline.
They don't really tell me that.
I think it's variable depending on who you're speaking to.
What are you speaking to a large company or a small company.
And.
I think we just have to let the data evolve and see how those conversations.
Our stations progress.
But we'll continue to have those conversations.
Got it thank you.
Thank you Dennis.
One moment for our next question.
Yeah.
Our next question comes from Brian <unk> with Baird. Your line is open.
Hey, Good morning, guys. This is Charlie on for Brian .
So I was curious if theres anything we can look forward beyond safety to get a good grasp on potential activity for either the oral PD lone or the RNA destabilizer.
As well as.
Looking at seven to nine with one of the patients becoming eligible to restart nuc therapy.
Just curious.
But what kind of proportion would you be looking here for the remaining patients in terms of defining success for you guys. Thank you.
Yes, Okay. Good question and maybe Microsoft here would you like to talk about 106, one of them one on one I'll come back on.
Right.
Sure.
Thanks, Robert for the question. So so when we look at they are oral PDL one inhibitor may be 101.
Obviously, we're looking at safety is our first.
The readout in the phase one studies, but we can also actually gain some insight on how this molecule is working and whether we anticipate efficacy.
We're looking at.
So we have several ability is to look at target engagement and target occupancy.
So from those studies, we'll be able to see whether this molecule is actually <unk>.
Engaging the target.
And producing some some kind of target relevant biological readout from the immunology side. So so that will give us some early hint on whether this molecule.
Has the potential to show HBV clinical efficacy as we progress into phase <unk> studies, So we will get that in.
The portion of the study.
Pretty pretty early and so we'll be able to say something about that by the end of the year.
When you look at maybe 161, RNA destabilizer oral compound.
They are clearly.
This field has has struggled with with safety safety is going to be a big part of.
How we assess this very early on.
As Ive always mentioned, we've done a very extensive preclinical safety assessment based on.
Our previous knowledge that we gained on AB 450, <unk> and.
In the peripheral neuropathy studies and so we've done 60 day two species toxicology studies I mean 90 day two pieces two species toxicology studies to reaffirm our belief that this molecule has a safety profile that we feel confident in going forward in the clinic, but that early obviously.
Phase one studies, where we'll be looking at safety pretty clearly.
And.
Paying clear attention to some of the some of the signals for further peripheral neuropathy are going to be important to us.
Once that once that is done then obviously, we will run right into a phase <unk> study, where we will be capturing that efficacy aspect of it the biomarkers specifically looking there.
At S antigen reduction.
And HBV DNA reductions in those parts of the <unk> study.
Okay.
Alright, and then on the seven to nine follow up of these nine patients who are now possible clarity.
I just wanted to clarify we now have seven patients remaining for follow up.
But I wanted to.
Just clarify, but actually so far only one patient has met the.
Clinical criteria to be stopped therapy.
There was one other patient who experienced what looked like some kind of increase in HBV DNA, but before that patient.
We stopped criteria.
<unk> physician.
The patient decided to restart therapy other than nine when you have one thats met the predefined.
Coal criteria for restarting therapy. So we remain really intrigued and interested in this data we think it is well worthwhile following up we have.
Some some interest obviously from <unk>.
Physicians and Kols and continuing to track these patients I should point out that many of these patients now multiple weeks into it.
Being off of therapy.
And so I think as we've alluded to we will track these patients and continue to report data as we progress through 2023.
Wonderful thank you.
One moment for the Charleston.
Yes.
Yes.
Our next question comes from Thomas Yip with H C. Wainwright Your line is open.
Hi, Good morning, everyone Thomas asking a couple questions for Ed.
So first a follow up.
On the top of the seven patients that remain on treatment and the <unk> study.
Can you tell us what is the range.
How many weeks these patients have gone off treatment and how frequently shoe expect updates this year from those patients.
Yes, so on the updates we've said, we'll provide an update in.
In the first half of the year.
And I'll, just say as we continued to progress during the year. So sudden used and will provide further updates.
I'm actually having to work from home today, you can tell I have a.
Horrendous head cold.
You don't have the data for the number of weeks of therapy in front of me. So I just wonder if there's.
Anyone else on the call it has that information.
I don't know, whether Mike macro Microsoft mostly just looking back on the deck here one.
One second bill so yes.
Patients.
Have been off therapy as of the last data update at least patients had been off therapy anywhere from sort of lets see.
To 20 call it call it roughly 20 weeks to 244 weeks.
Or more that's right. So as of the last day to update remember so patients. Obviously, you can continue to track that forward and get a sense for where patients.
Yes that is.
Slide 13 actually in the corporate deck, which you can see the data for the nine patients and this was what we reported in December last year.
So Mike has given you the range of weeks and then we can add on I guess, a few more weeks since the December update last year.
Thank you Thomas right, Yes, yes, you alluded to seven patients a month in mind so.
A couple of months.
Being a more.
Four weeks I suppose.
Okay.
Yeah.
And then as you as we continue to see this data with more patients.
What do you expect some findings.
Continue to collect that could impact the ongoing phase two combination studies.
You mean, what data could we expect from these remaining seven patients.
Or more specifically what.
What kind of what kind of findings will you expect.
These patients that could potentially.
Change or alter or Andy.
The phase two combination studies that are either.
During or new cohorts.
Okay understood.
I mean, obviously, we want to continue to attract them.
I hope that all.
Not too many more.
Meet the criteria to restart treatment, but that's.
One potential outcome.
Another potential outcome as we potentially get a few who do actually go on detectable.
We just have to track and obviously, we'll report if that does happen.
And then the other one Tom is that actually.
They kind of continue to stay as they are.
Which is low levels of HBV DNA low levels of surface antigen not meeting the criteria to restart treatment.
No.
Detectable.
Which I think would be a demonstration, but actually treatment with <unk> nine and the nuc.
Does actually get these patients to a position.
Whether they're able to come off therapy.
I also indicate that.
The ultimate combination of functional cure would be seven to nine new and then a third agent.
Designed to further boost the immune system, which is why our PD Lone program comes in.
So that I think would be.
Interesting information and then obviously, we're looking for the same thing in a phase Iia study is whether or not the addition of interferon and all.
<unk> hundred plus or minus NEVA results and further S antigen reductions than <unk> alone and then obviously in the follow up period will be looking to see how these patients respond when the off trade.
Got it. Thank you so much I, perhaps one final question from us.
Speaking.
DCP 300 combination study.
What type of preliminary data should you expect to be announced in the second half of.
This year from this study.
Yes, I think the best way to think about that.
Corporate deck, we've kind of laid out the trial designs for both the <unk> 300 study.
So we're going to be in this phase.
The patients have received <unk>.
<unk> 300.
Or the placebo.
And therefore, that's the type of data that we will be sharing later this year.
We won't be.
April just because of the length of the study.
A report and the treatment days for a follow up data. So it's going to be somewhere if you look at slide 18.
We're in that kind of dark red.
Phase <unk>.
<unk>, receiving <unk> 300 or placebo.
Okay got it. Thank you so much again for taking my questions.
Good morning.
One moment for our next question.
Our next question comes from Keith Mackey with Chardan. Your line is open.
Yes, a couple of questions.
For the one.
Bob.
Okay. We are unable to hear you.
Yes, sorry.
Yeah.
Can you hear me now.
Yes, a little better.
Yeah.
Okay.
For the one patient who was off treatment and then met the criteria to restart how long were they able to stay off treatment.
Uh huh.
Can I get back to you on that K I don't know that I have that information immediately at my fingertips.
Okay.
We have that available if you've got if you'd like.
Okay.
So the one patient that required restart because of the protocol defined criteria.
<unk> discontinued follow up week 36 after after 36 weeks after they stopped all therapy.
Yes.
Yes, Thanks, Mike equivalent slide slide 13 in the deck, the little asterisk cut the bottom.
Yes.
Okay and then.
For Mike <unk>.
<unk> pro as you take that into the clinic.
Once you get beyond.
Safety.
And want to evaluate it.
Patients who may have the virus.
What might that study look like what would be maybe.
Targeted course of therapy, it's going to be like a five day like tax limit or maybe give us some thoughts about that.
Yes.
Yeah. Thanks, Peter So I think.
The.
We haven't really.
Sort of communicated with our clinical development plan is going to be but you can imagine based on what you know what some of our competitors have done in the field.
We would be looking at potentially readouts that wed look at viral load decline they could look at.
We've got a reduced hospitalization one of the things that we're really quite interested in is as we go forward as.
Does this molecule or ultimately our combinations produce.
Any effect on reduction in symptomology or potentially pre exposure prophylaxis. So so so those are the kinds of things that we're targeting in and sort of mapping out our clinical development plan.
And.
Eager to get those started as soon as possible.
Okay.
And then.
Once you have the second compound ready to go into the clinic.
How how soon would you evaluate it as a combo therapy at least in terms of safety.
Well I mean, we could do some preclinical assessments will look at combination safety.
Yeah.
And we do a lot of a lot of that sort of in let's say in the preclinical.
Environment.
Once we once we get.
Our second molecule.
Nominated to move through IND, enabling studies, we will do our phase one compounded with a single agent and we have certainly based on.
Previous.
Developments in <unk> will have to show that it works and is safe by itself and then as rapidly as we possibly can assuming we all those ducks lined up now we will get into combination but.
Right now we're looking at no hopefully a fairly short early clinical development program because of the short duration of therapy that you need to show some kind of anti viral effect.
Hopefully, we will accelerate our ability to get into combinations.
Okay, and then just a final question on the litigation with <unk>.
Update you can provide as far as the next step in that process.
Thank you Kay.
Unfortunately not.
Stick to a policy that we've had since we filed that.
Case last year, we just don't comment on the ongoing twist some stands the case so.
No you didn't see any update.
Press release, our prepared remarks.
Although frustrating for you guys.
Which I understand.
That one's a no comment.
Okay very good thanks.
Thank you so much.
One moment for our next question.
Our last question comes from Roy Buchanan with JMP Securities. Your line is open.
Hey, Thanks for taking the questions I had a few for Covid first I guess, so three for three.
It looks very potent do you anticipate once daily oral dosing.
When do you think we might see that preclinical data first presented for that and then the IC 50, presumably that's in vitro and not sell base can you give us any details on what system that was thanks.
Alright, well.
Yes, our PK so we have.
One presentation, that's going to be at <unk>. This year in a couple of weeks.
I will highlight.
Sort of the entire in vitro profile of the molecule itself.
I mean, we have.
Anticipate submitting a couple of abstracts.
Other meetings coming up in the very near future too.
Also share.
Preclinical data that we have.
The on the molecule so hopefully some of that will be rolling out.
Shortly for everyone to see.
Let's see what our exciting molecule, we have maybe 343.
Okay, Great and then any comments on the once daily dosing.
I can say, our PK looks very good.
We are in multiple species, where you just have to see once we get into the clinic, what the dosing frequency you needs to be but right now we're pretty optimistic.
Okay, Great and then on the 79.
Can you just remind us the criteria for restarting the nukes for that patient that had to restart what's the criteria.
Good question.
<unk>.
I can follow up later, if it's not.
No.
One is not on the slide that's what I was looking at so we'll follow up with you.
Okay.
Okay, Great and then I had.
So it looks like gsk's limiting and that would be.
Phase III the <unk>.
Primary endpoints.
Baseline S antigen below a thousand it looks like maybe that's 15% to 20% of the population in their phase III is that consistent with kind of your view of the overall CHP population and then it looks like pretty much all of the patients that you have off therapy, maybe one.
We're above a thousand does that go away.
Am I looking at that correctly. Thanks.
Good question I don't know that I can comment on the GSK trial.
But the.
Nine patients. So we had discontinue I think had.
All sorts of historic.
Starting to pass antigen levels.
We can get that information for you right.
Right.
Just looking at the <unk> presentation. It looks like maybe one is below a 1000, but the rest.
It looks like they're above okay.
And then I guess just for the interferon combo readout. This half I know you guys have been asked this before just what are we.
Key points that we should be looking out for for that data. Thanks.
Yes, so I mean.
As I said in my prepared remarks, I mean, I think the key thing that we.
Would want to see a further reduction in S antigen.
So you treat with 79 and then.
Potentially.
After you add in these other agents a further reduction in S antigen.
Which could be reflective of.
<unk> immune response.
But I will add the caveat that we've seen in other studies doesn't necessarily happen immediately with interferon.
And sometimes it takes a while sometimes yourself to the interferon therapy has stopped.
So.
We'll have to see how our data pans out on.
We'll make the appropriate commentary when we when we do that update.
Okay, great. Thank you.
Ladies and gentlemen, this does conclude the Q&A portion of today's call I'd like to turn the call back over to Bill for any closing remarks.
Well, thank you very much.
For joining us this morning.
So I think for my voice managed to hold up we.
We do appreciate your continued interest in our abuses.
We especially look forward to providing you with further updates.
As we progress the development of our HPV and coronavirus assets.
Thanks, again for joining and operator that concludes our call.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.