Q2 2020 Regenxbio Inc Earnings Call
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No we won't come back to your question answer session and instructions will be given at that time. As a reminder, this conference call is being recorded I would now like to turn the call over to Mr. counter Christmas Chief Legal officer for rejects bio you may begin.
Good afternoon, and thank you for joining us today with with US our Ken Mills rejects Bio's, President and Chief Executive Officer, Dr., Steve Nicola, Our Chief Medical Officer, and get the system, our Chief Financial Officer.
Earlier, this afternoon or Gentex bio released financial and operating results for the second quarter ended June Thirtyth 2020.
The press release reporting our financial results is available on our website at www Dot rejects bio dot com.
Today's conference call will include forward looking statements regarding our financial outlook. In addition to regulatory product development and other business plans.
Forward looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and Ken by the end can be identified by words, such as expected plan will.
So people leave should intend in other words of similar meaning.
Any such forward looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussing discussion and analysis section Overgenerous Bio's annual report on form 10-K for the full year ended December 30, Onest 2019.
Hey, comparable section of sections Overgenerous Bio's quarterly report on form 10-Q, and other filings, which are on file with the Securities and Exchange Commission and available on the Fccs Web site.
Any information we provide on this conference call is provided only as of the date of this call August six 2020, we undertake no obligation to update any forward looking statements. We make on this call and account new information future events or otherwise.
Please be advised that today's call is being recorded and webcast.
In addition, any unaudited pro forma financial information that may be provided is preliminary and does not support to project financial positions. We're operating results of the company actual results may differ materially.
I'd now like to turn the call over to Ken Bills, President and Chief Executive Officer of rejects bio Ken.
Yeah.
Thank you Patrick good afternoon, everyone and thanks for joining us for a second time this week.
Some of US today are updating life from our offices in Rockville, Maryland, and we hope that everyone is safe and well on today's conference call. We will provide a few updates on recent progress advancing our pipeline of gene therapies and that will provide an update on financial results for the second quarter of 2020.
Steve is here as well for updates in questions about our clinical programs, including our latest rdx three onefour data.
We're now a little more than halfway through the year of course and I'm pleased to report. The 2020 has been very productive for rejects bio.
Right the challenging backdrop of the covert 19 pandemic.
We've made important strides in our clinical development programs and key decisions that have allowed us to broaden or pipeline, while evaluating and prioritizing promising gene therapy candidates.
As I mentioned earlier this week, we held the conference call that was led by Steve with several of our leading retinal specialists to share an update on the rdx three one for program for the treatment of what A.M.D.. So invite all of you to listen to that call. If you haven't already done so.
The data from our phase one two way study of Rdx three one for has provided us with evidence of a compelling clinical profile for the potential treatment of let A.M.D. in a broad range of patients.
Patients from this study and cohorts three four and five have demonstrated stable to improved visual acuity and retinal thickness as well as meaningful reduction and anti VEGF injection burden out to one year and as we reported in April. We also have data from cohort three out to two years, which gives us confidence in the long term.
Durability of this gene therapy.
We will use the data in our learnings from this first in human study to inform the design of our pivotal program, which we expect to initiate and the second half of this year, we look forward to providing further details in the months to come.
Also announced earlier this week, we had advanced our phase two trial for the Super Croyle delivery of RG X three one for using the SCS micro injector for the treatment of wet AMD.
We plan to dose the first patient in this randomized controlled study known as aviate in the coming weeks and expect interim data from the first patient cohort by the end of 2020.
We also plan to use the supercross idle delivery route for the treatment of diabetic retinopathy, which is a leading cause of vision loss affecting approximately 8 million people in the United States.
We expect to initiate a phase two trial in the second half of 2020 with interim data expected in 2021.
In July we reported an update on the progress of clinical programs for rare genetic diseases and Steve will now update on the current status and expected milestones related to these programs Steve.
Thanks, Ken.
As previously announced we have completed dosing of three patients in the second cohort of art Phase one two study of our Gx 121 for the treatment of NPS too.
These patients were dosed interest externally and our Gxfour hundred 21 reason reported to be well tolerated in patients across two dose levels with no drug related serious adverse events.
We expect to provide additional data from both cohorts in the study as well as a program update later this year.
We also expect to provide a program update for phase one two clinical trial of RG actually won 11 for the treatment of MPS one by the end of 2020.
Last month, we reported data from a patient with severe MPS, one who is dosed interest externally under a single patient investigator initiated study at Chuck Chuck Children's.
At week 12 after administration of our Gx 111, an increase in I'd you a enzyme activity was detected as was a sustained decrease in heparan sulfate and the cerebral spinal fluid.
In addition, neuro cognitive evaluations indicated that the patient continued to acquire cognitive developmental skills at a normal rate at week 32.
We're very encouraged by the clinical and biochemical indicators for this study.
We are committed to continuously evaluating our portfolio of single administration gene therapy candidate to drive innovation for patients and further leveraging the expertise of our team.
We've been working for some time on our Gx 181 program for the treatment of the CNS manifestations of the on two disease also known as batten disease.
As we work closely with the community and gotten to know many of the patients and families. We were struck by the tremendous unmet need for therapies to address okcular manifestations of the disease.
Building upon our understanding of gene therapy, and the Guy we are bringing forward and new program. Our gx 381 for the treatment of Okcular manifestations of CLM too.
Our gx Threeeighty one is designed to use the Avi nine factor to the liver try peptides l. pet today's one or TPP, one gene directly to the right now.
We believe onetime administration of our Gx Threeeighty, one could provide a durable source of TPP want activity in the retina.
Thereby potentially preventing visual decline.
We plan to submit an eye Andy for this program in the second half in 2020 and initiate enrollment in the first half of 2021.
We have also opened two non interventional natural history studies to better understand the after their manifestations of CLM to disease.
This expansion reflects our commitment to the CL into patient community.
And we'll build upon the collaborations in relationships established through they are Gx 181 program, which also continues to move forward.
We expect to file an eye Andy for RG X 181 by the end of this year and initiate enrollment in a phase one two trial in the first half of 2021.
With that I'll turn it back over to Ken.
Thank you Steve these are encouraging updates.
No. Additionally, today, we're announcing that we've made it difficult decision.
To discontinue internal development of RG X five a one for the treatment of homozygous familial hypercholesterolemia or HR FH.
Rgs fiber one was one of our first clinical stage gene therapy programs and we are grateful for the support of the HR FH patient community over the years.
However, we've seen the landscape of treatment option shift dramatically since we began the program with the emergence of several new therapies that lower LDL cholesterol and these populations.
The target product profile has changed so while our gene therapy approach supported signs of biological activity at the second dose level, we acknowledge that further pharmacology work is needed.
We will look for opportunities to support continued advancement of this program through business development.
And certainly focus on ways to share clinical trial data that benefits patients in foster scientific discovery in cooperation with the investigators in the future.
And just to wrap up our plans for the second half of 2020 also include progress on our potential aviate based treatment for HP, where preclinical data has demonstrated biological activity and an animal model of inflammatory edema and inhibition of kallikrein comparable to other anti kallikrein treatments.
And we have plans to announce more details around the treatment for neuromuscular disorder using aviate.
With that I will now like to turn the call over to visit per view of the financials.
Thank you Ken Progenics bio ended the quarter on June 30, 2020, with cash cash equivalents and marketable securities totaling $339.2 million compared to $400 million as of December 31st 29.
The decrease was primarily attributable to net cash used in operating activities of $57.1 million.
Revenues were $16.6 million for the three months ended June Thirtyth 2020, compared to $7.9 million for the same period in 2019, the increase was primarily attributable.
To a $11 million increase in royalty revenue recognized on net sales of Xeljanz law in the second quarter 2020 total net sales those old dense since launch in May 2019 are greater than $705 million.
And were dentist bio is eligible to receive a milestone payment $80 million.
Upon the achievement of $1 billion in cumulative net sales of full Jens wrong.
Research and development expenses were 38.1 by $1 billion.
For the three months ended June Thirtyth 2020, compared to $29.5 million for the same period and 29 to increase was primarily attributable to personal related cost as a result of increase sanco.
Fences associated with conducting clinical trials for our lead product candidate laboratory and facilities costs and externally sourced services for pre clinical regulatory and manufacturing and related activities.
General and admin.
General and administrative expenses were $15.6 million for the three months ended June Thirtyth 2020, compared to $13.4 million for the same period. In 2019 decrease is primarily attributable to personal related cost as a result of increased headcount and profession.
No fees for advisory and other services.
Net loss was $33.8 million or 91 cents basic and diluted net loss per share for the three months ended June thirtyth 2020, compared to net loss of $1.5 million for four cents basic and diluted net loss per share for.
The same period in 2019 as of June Thirtyth, we had approximately 37.3 million common shares outstanding.
Based on our current operating plan for Dennis Bio expects its balancing cash cash equivalents in marketable securities to fund the completion of its internal manufacturing capabilities and clinical advancements of its product candidates into 2022 with that.
I will turn the call back to Ob, Ken Kenobi, meaning the fourth fee with you.
Okay of it.
As we've mentioned before Oragenics bio has an extensive footprint and gene therapy.
Aside from our own internal pipeline and our NAV vectors are the basis of many partnered product candidates, including one marketed product Novartis is agenda and several others in late stage clinical development.
The extraordinary milestones and achievements from our partners as well as the progress in our internal pipeline provide additional validation to our proprietary NAV technology platform and further demonstrate a transformational impact that can come from a onetime administration of gene therapy.
Now as Bret mentioned, we continue to track the positive progress on Xeljanz month, which uses the Navy nine vector on its recent earnings call Novartis cited strong global momentum for the therapy. Despite cobot 19 with newborn screening continuing their progress in the United States and additional growth driven by geographic expansion outside of the U.S.
Yes, we're also pleased to see the positive regulatory developments in Europe. This quarter with the conditional approval of the intravenous formulation and the robust uptake in Japan since first months of launch in that market I.
I continue to be encouraged by the great potential for this therapy.
It's truly exciting to be experiencing the momentum that we have at the company today and after more than a decade of steadfast effort and focus our business includes abroad and expanding pipeline of gene therapies were on the cost of initiating our first pivotal trial for RG X three one for a remarkable milestone.
We look forward to making further strides towards improving lives through the curative potential of single administration gene therapies and remain dedicated to this mission I'm proud of and grateful to our talented and dedicated employees to drive our business forward. Despite the challenging backdrop as the cobot 19 pandemic.
And with that.
Will end this portion of the call and we'd like to open up for questions operator.
Thank you we will now begin the question and answer session.
Please press Star then one on your Touchtone phone, maybe Sean you may need to pick up the handset first C. Fresh in the numbers. Once again, if you do have a question. Please press Star then one and you touched on phone.
And our first question comes from Gena Wang with Barclays. Please go ahead.
Thank you for taking my question two questions first one once we got a long life assets.
Thanks to trial Wong on place.
Have you thought about using two doses full two injection. So the first close so that caused the Walter.
On the backup.
And also how the leasing them quite acutely component to the Lumpiness.
Procedure.
My second question in that regard CLL Q.
Can you give us a little more color regarding.
Seem to sell.
Obsolescence for last on the how much overlap.
For the patients on how would you just so far.
We should selection.
Hi, Jana. This is again those are great question. Some in a couple of Steve you're on thank you, Okay, all right great.
The.
Yeah, let into being a different spots in times of Copel. So thanks, Jennifer for those get questions. Yes, so suprachoroidal the existing experience with suprachoroidal delivery using that specific that device CS micro injector from clear saw.
It is with the 100 microliters.
And that's our first cohort is going to be looking at the high goes.
Number of key fees per high but within a 100 microliters.
That highest dose that we were able to get too in the sub retinal study. So you raised the good point given the preclinical data that suggests that with Super Coronado delivery, even with one injection you've got about.
Half of the the globe or the retinal surface covered with a 100 microliter Super coil injection. So that could have been a possibility to consider looking at for example, 50 microliters in to cooperate injections or 100, microliters, we decided that right off the bat to take that step by step and.
Let's start with a 100 microliters single injection, but selling right up to that.
2.5, 11, GC dose there, but we are going to in the second.
Or use that same.
Concentration and give us seconds dose of 100, Microliters 180 degrees on the other side of the high to do exactly what you're raising.
I have the potential to cover the entire retinal surplus.
And early days in terms of Supercross oil, but we thought that was the best way to get the.
The earliest and quicker learnings while also leveraging how much has been learn from the over thousand eyes that had been dosed with the Clearsight device using 100 Bankrate leader single injection.
Your your second question Segway into our newest stock dealer program.
On our Gx three one for sub retinal announced Supercross will be our gx three a one for CLM to DC.
And it's a great.
Question in terms of when do you see the outage duration and.
The systemic and neurologic.
Hi, though the disease relative to the Okcular tied to the disease and it's really that time course that.
Interestingly as is what allowed us to realize how much of a big gotten unmet need exists where given E. R. T treatment, which is the dressing.
Systemic complications for these patients their living longer, but now that really big unmet need that we're hearing from families repeatedly is that the patients are now going blind.
So this has become a very.
Clear area, where now, especially for for us with our experience and also our vectors, where we have real proof of concept and validation for.
Retinal delivery it next on for perhaps to go in this direction.
The if you think of the time course, it is a little later than the time course, where you see than the.
Non okcular manifestation.
Initially a ball, but it is the type of thing that there's enough natural history out there in terms of.
How.
Even the imaging evolution evolves to help us decide what's the right age groups to.
Enroll even in early development to have patients where were going to be likely to evaluate and have power to evaluate whether a gene therapy onetime treatment is actually having an impact on the natural course and that the disease in terms of the okcular manifestations and we're going to.
Gather more information by starting as we announced two non interventional natural history studies.
Theyll end to patients.
Okay.
Just like what about the beach to rescue injection criteria.
Comparison to the supply yes.
Yes, thank you I accidentally skipped over that one.
So in our first in human study as we've often talked about we had a very low bar for re treatment so that stack the deck against us in terms of.
Which patients and how many reinjection might occur.
Now that we have actual proof of concept and clear evidence of beneficial effect across a range of doses.
Albeit with sub retinal delivery, we feel we're in a very solid position too.
Start moving that bar higher two or more.
Traditional bar.
You can see in some of the other later stage.
Studies that have had retreatment criteria. So that's a good point where.
Already right from the start with our Super crude oil.
Phase one two studies.
Per Mcf.
Wet AMD be we'll be using kind of more traditional.
Retreatment criteria.
Thanks Sina.
Next question operator.
Hello.
Our next question comes from Geoff Meacham with Bank of America. Please go ahead.
Hey, guys. This is alec on for Jeff Thanks for taking our question.
First on five a one could you help us understand a bit more around the decision to discontinue the program I get the evolution of the competitive landscape, but that the transaction and television or something on the efficacy side also inform your decision and then on the deal into program.
Tried some more color on how the preclinical work for 21 helped inform development of 381, and if you could also speak to the nuances of CPP, one delivery to the retina versus interest externally and the case of 181 that would be great. Thanks.
Sure Alec Steve maybe I'll start off here and you can jump in as needed right with respect to final one we certainly as I mentioned to expect to bring when the investigators have had a chance to work through all of the data with us.
Bring forward more of the findings with respect to the science and the status of.
Patients that weve enrolled to date I really think that.
With that understanding.
What we saw Alec was what I described which is.
Certainly the landscape has changed there have been treatments coming forward and developments that are different than when we initiated this trial several years ago, some of which are having significant lipid lowering effects cholesterol lowering effects clinically this change and raise the bar for our target product profile in as well as the risk benefit and.
We definitely saw from from dose level to with and some of the early examples while we felt we could treat the.
Manifestations of these transaction elevations with prophylactic steroids protocol I think we've acknowledged that steroid protocols. In these patients are also things that elevate the cholesterol levels naturally even in healthy patients and so it's something that pharmacologically, we wrestled with and I think with respect to that data coming.
Going forward, we'll look to work with our investigators that pen to bring additional data when we have an ability to do so with them.
On the 181 and 381 conversation I think as Steve alluded to with respect to the compound the answer to the genius questions is this really it wasn't so much the preclinical work that was going on around when a one as it was the engagement with the community in the ceiling to batten disease.
Hearing about the approval of an enzyme replacement therapy treatment for the CNS manifestations.
And how it was being.
We're been received in the market evaluating the need for gene therapy brought up a real additional unmet need in the okcular manifestations of the disease and as Steve alluded to there maybe a bit more of a late non sat here, but you know the prevalent population of.
Patients.
Currently on it even existing therapy is there and waiting for some solution thats not met by existing cerebral ventricular enzyme replacement therapy, and we wouldn't expect would be met by an interest cisternal approach either.
So the idea was to leverage our understanding of sub retinal delivery to call on experiences like our.
Preclinical investigators and others have had with programs like luck sirna and and deliver the gene that encodes PPP one directly to the site of action where in the retinal cells where.
The disease pathology is occurring and so we view this on a going forward basis is probably something that's going to become not unusual for gene therapy with different routes of administration to treat these multisystem diseases and in this case, we think a intra cisternal approach for the CNS manifestations, which.
There are quite severe as well as a contract killer approach to address the vision loss is going to be important for.
Basically addressing all of the unmet need that can be addressed in sealing too.
Perfect. Thank you very much and congrats on the progress.
Sure. Thanks, again, Alex dialing in and operator next question.
Our next question comes from many.
So higher with SVB. Please go ahead.
Hey, guys.
A couple of quick ones the first one for bed.
How do you guys think like a strategically around the prevail stake in any other possible equity stake you have in the result of other lysine transactions do you see of the strategic assets purely financial assets to be monetized whenever the valuations appropriate like how do you view them apropos.
Being control assets in terms of equity or just another pool of cash.
And then one for one for Kenobi when you think about reviewing your gene therapy pipeline and changing and changing standards expectations.
How.
How high is the bar what did the bar to consider de prioritizing or going back and looking for a different for a different assets or an indication going through a different lifecycle management strategy.
For a later stage assets.
As opposed to something of filling in early stages of each off.
Thanks, Many glad you got bumped up in the queue today and those are good questions that wanted to take the first one.
Yes. Thanks, Randy further question, we view the assets that we have in licensing companies when we do take equity assist alternative tools of.
Capital and.
Ways.
Continued funding the company General Dave performed incredibly well in terms of if you normalize and so what we would get on a cash transaction licensing basis. So.
Thats kind of how we use our view equity stakes in currently public companies.
And I think the question about managing the pipeline.
Look I think for us by the time something gets to a decision about later stages of development.
We not only have established.
A strong foundation on the basis of proof of concept from clinical data. We've also in parallel continued to too deep digging into kind of the pre commercial and commercial readiness and additional need.
And that maturation process, certainly a big contributor to making decisions to advanced things from proof of concept.
In clinic stage, two late stages of development, including pivotal like with our sub retinal Rgs three one for program, which as I mentioned. This is the first example of us advancing something forward and I think that will be applied to programs on a going forward basis.
It's it's something that we obviously have awareness of upstream when we're identifying programs for the portfolio but.
Obviously, the contributions of what happens with respect to the proof of concept outcomes in the clinic as well as the commercial landscape are our major an important factors that go into continuing to advance those things through the funnel.
Thanks, Manny operator next question.
Our next question comes from ball on let's start with Chardan. Please go ahead.
Hi, This is Sam on behalf of Bhola, Thanks for taking my questions.
Question and a follow up first.
Got to epidemiology, if you have to represent the markets RG ex wasn't one and 381 targets and I've been diagram is the circle for 381 sitting completely inside that for at 181 or would the venn diagram represent two intersecting circles, where each product would have utility and distinct population with some overlap.
In the middle.
Yes, I think.
Thanks for the question the the assessment has been that.
The vast majority of patients that present with CLM Q disease.
Genetically and Phenotypically will emerge with manifestations that are both.
Central nervous system, Neurodegenerative et cetera, as well as Okcular envision loss as Steve alluded to there there can be a frame shifts sometimes in that presentation.
But I think in terms of how you're thinking about event diagram Ana.
Math Guy so I like that analogy.
There are significant overlap, but for as a component of time. So maybe the incident in population is going to be coming in with.
Obviously, CNS symptoms first as I alluded to but eventually we see prevalence in all patients, especially has gene therapy or existing standard of care.
And start to address the CNS manifestations that vision loss becomes a substantial and severe impact as well.
And I'd add that.
Helps quite a bit in our learnings and and talking to the patient community, where these patients are in the healthcare system and.
For lack of by treatment option for the the blinding eye disease aspect that these patients are going to develop.
There isn't anything to be done. So some of these are sent but with an actual treatment.
Theres, a very feasible approach to having these patients seen in a timely fashion. So if a potential therapy come forward there could be.
Great penetration for these needy patients.
Thanks for the question operator.
So back into cash.
Our next question comes from Matthew Harrison with Morgan Stanley. Please go ahead.
Hi, all thanks for taking the question. This is Carter on for Matthew So just to from US for MPS I just want to can you just talk about how you plan to engage with regulators and and I guess.
To what extent you want to see the data developed before you have conversation.
Regarding this program and then just quickly on Threeeighty one.
What steps do you need to complete before submitted submitting the I'd. Thank you.
Yeah I think.
Stephen I'll take this I guess.
Feel free with additional color. Thanks, Cotter I think.
Appreciate the focus on the Neurodegenerative.
In CNS aspects of the pipeline.
We have we've chosen and I think we've said this before you MPS, one and MPS to have been.
Decisions for us that whereas much driven by the impact that gene therapy can have but also the understanding of the of the natural history. In these diseases and we pointed to the examples of yeah, I think that the consensus among experts that we've engaged with about the correlation between heparin sulfate as a biomarker and.
Degenerative neurological conditions in severe cases of MPS, two and MPS one has significant.
We obviously had the benefit of natural history occurring because just like Steve alluded to with recently more recently sealant to patient MPS, one and MPS two patients have been part of a system of care, but also treatment for years now thanks to the early interventions developed around here.
The therapy, and so gene therapy is coming into that with.
Understanding of an improvement of a profile addressing additional unmet needs, but also that more rich natural history, then maybe a de novo diseases because of that I think conversations even from the very beginning of this program have been able to be informed by a lot of whats known and you get that even when you would.
Talk with people within the agency or within the community. So I think thats, an important point of emphasis there.
With respect to.
381, our guidance here is that we are expecting to file an R&D by the end of this year. So.
It's August and typically when we're talking about something on the order of months it really is about.
At a stage, where we feel like we've established.
Lead candidate based on proof of concept work in gone through opportunities to sort of assess the type of dose. We're using what we we I guess, obviously have decided and stated that we're using the Avi nine vector, which is something we were already familiar and comfortable with with respect to the profile of 181.
In the CNS, so that formulation in that approach with that vector in that transgene product were things, where we already had foundational evidence of obviously transduction an expression in different cell types. So we're really doing is steering this now too.
Final work that would prepare us for clinical readiness and safety around the Okcular administration and of course I guess.
I'd be remiss without adding we're using the sub retinal delivery approach. So we're also able to borrow from that clinical experience as well as approved product experience when we head into the clinic here.
Steve did I Miss anything on that.
Well I'll, just say as the pad along learner here nothing cat.
Well Duncan good point, thanks for extending the analogy.
Okay operator.
Yeah. Thanks Connor.
Our next question comes from Okay, if each with RBC capital. Please go ahead.
Terrific. Thanks for taking my question allocated from RBC.
The first on through one for Scott how are you thinking about a pivotal trial design here should we assume that the studies conceptually similar to the portal deliver assistant trial that Roche for something wrong or are there any differences from that trial that you'd like to highlight and then maybe as a quick follow up to that question. How should we think about the cost of that trial.
And then the second is are there any updates on the IP disputed passage. Thank you.
Yes.
Okay I can I can take the three one for pivotal design question first and then.
It's often on the latter part of the question so.
Thanks, Luca yes, so you raise the.
Or delivery system and the archway pivotal design so.
That delivery approaches.
Somewhat similar in that it certainly shooting for increasing durability, but it's also very different in terms of still being the paradigm of needing repeated injections. It's just that you can get it down due to once every six months by being able to inject into.
In two welling device, so that aspect wind to be very important also from a design standpoint, so I'd say they had to consider the aspect of definitely being a rejecting.
Into the court delivery system every six months, so that could allow them to think differently about.
How they're looking at visits leading up to that Reinjection in our case. This is intended to be a onetime treatment option at least for a majority of patients and in the other patients decrease.
The frequency of of injection.
So I, but I'd say at least in a general sense. You can you can think of the same type of.
Pivotal design considerations, we'd be thinking about so.
Whether even with those differences aside in a wedding empty population, we now PCBA.
Is the required pivotal endpoint, we know with standard of care, albeit frequent routine injection stat.
In that setting it makes sense to look at a active comparator and consider noninferiority. So a lot of this locate sounding like a similarities.
Beyond.
That's.
Also other similarities based on the patient population of what type of duration a follow up.
You might need in terms of safety and efficacy and also the general size.
So if that it's at least a precedent out there for people to look out we are aware of that by we certainly are rolled up our sleeves and looked at our particular target product profile our particular.
Results that were seeing in how we're going to finalize the design of our pivotal study.
Yes. Thanks, you Thats the first part of the question.
First question Luca the second on on the IP dispute with passive no theres nothing to update with respect to that communication. We have notified them have obviously, our concerns over there infringement of intellectual property and they've received that and they're aware.
Of it and that's where that stands I do expect that there will be updates on actions to be taken though with respect to RFP in general and especially for companies that are in later stages. The developments in companies that are heading towards commercialization passage of course. This I mean still at a preclinical stage.
We notified them and others.
So of.
These infringing actions in our view and.
It's now time for us to transition to take action, where the focus will be on those companies that are in later stages of development are heading towards commercialization. We think this is important we've been saying this for a while about representing the interest of our shareholders with respect to this IP and so we'll be updating on this.
And your future.
Thank you at this time, we have no further questions trying to call back to final remarks for Ken.
Okay, well thanks, everyone. Thank you operator, and thanks, everyone, who joined US today. We appreciate the questions. We appreciate the interest appreciate those of you that spend.
Two days with us reviewing data on reviewing progress.
We're incredibly excited about the opportunity for Genex bio to deliver value for patients to deliver on our mission and of course for our partners stakeholders and shareholders. We hope that everyone stay safe see as well and have a great night.
Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.
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