Q3 2022 Geron Corp Earnings Call
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Good morning, everyone welcome to the Geron Corporation third quarter 2022 conference call I am Erin find gold Jones, Vice President of Investor Relations and corporate communication.
[laughter].
I'm joined today by the following members of Gerrans management team Dr.
Doctor, John Scarlett, Chairman and Chief Executive Officer.
Olivia Bloom executive Vice President of Finance, and Chief Financial Officer and Treasurer.
Doctor Faith, Eller Executive Vice President and Chief Medical Officer, and Neil <unk> Executive Vice President of corporate strategy and Chief commercial officer.
Before we begin please note that during the course of this presentation and question and answer session. We will be making forward looking statements regarding future events performance plans expectations and other projections, including those related to the therapeutic potential and potential regulatory approval.
And they tell us that anticipated clinical and commercial events.
And related timelines, the sufficiency of Gerrans financial resources and other statements that are not historical fact, actual events or results could differ materially.
Therefore, I refer you to the discussion other than dirt the heading risk factors in <unk> quarterly report on Form 10-Q for the quarter ended June 32022, which identifies important factors that could cause actual results to differ materially from those contained in the forward looking statements.
<unk> undertakes no duty or obligation to update our forward looking statements.
And now I will turn the call over to CEO , Dr. Scarlett chip.
Thanks, Aaron Good morning, everyone. Thanks for joining us today.
Throughout the year, we've highlighted our vision for <unk>, which is to become a leader in the treatment of hematologic malignancies.
The strategic pathway to achieving this goal is defined by our expected journey to develop and commercialize Intelsat.
Thank you.
Just on the Intelsat phase III data in lower risk Mds and in relapsed and refractory myelofibrosis. We believe <unk> is a highly differentiated compelling clinical profile.
First as a telomerase inhibitor and Intelsat has a unique mechanism of action that strikes at the very heart of these malignancies by targeting the malignant stem and progenitor cells that drive both lower risk Mds and Jack I relapsed and refractory MF.
Second the phase II data also provided strong evidence for disease modification at a molecular level in both phase III studies, we reported depletion of mutated entitled genetically abnormal cells that have been correlated with the direct clinical benefits and Intelsat, providing additional evidence.
These modification.
And which also has potential for disease modification not only differentiates it from other currently available therapies, but also directly addresses critical unmet needs in lower risk Mds and relapsed refractory MF.
We expect we will provide a needed treatment option for patients with these diseases.
Third in both lower risk Mds, and relapsed refractory MF patients treated with Intelsat.
Saw unprecedented durability of clinical effects.
For instance.
We will describe an ash abstract published today in which we reported the approximately one third of the 48 patients in our phase III lower risk Mds study.
Despite a medium pretreatment transfusion burden of six RBC units per eight weeks.
<unk>, one year or more of transfusion independence.
Similarly in our phase II relapsed refractory MF study median overall survival for patients improved to almost twice as long as it has been reported in the medical literature.
Based on these attributes IBM, Intelsat and compelling phase II data, we expect potentially highly differentiated clinical profiles from the results of our ongoing <unk> phase III trials in these indications.
We're therefore very excited by the lineup of expected milestones coming soon and over the next two years.
We expect disclosure of topline results or CLR from our emerge phase III trial in lower risk Mds and only two months from now in early January of 2023.
<unk> is positive we expect great value will be unlocked for both patients and for shareholders.
Assuming positive CLR. The next expected key milestones are regulatory submissions for <unk> in low risk Mds.
Today, we expect submission of the NDA during the first half of 2023.
The EU MAA during the second half of 2023.
As Jay will discuss in a few minutes, we have been actively preparing for many months for both disclosure of CLR in early January 2023, as well as for these key regulatory submissions later in the year.
Similarly, we have also been preparing for potential commercialization of <unk> and have recently made key hires across the team in order to begin building the foundation for a successful commercial launch for lower risk Mds.
Finally, becoming a leader in the treatment of hematologic malignancies requires breath of effect.
Thus the next significant step is to bring <unk> to patients who suffer from Jakafi relapsed refractory myelofibrosis.
To achieve this we are working towards having an interim analysis from our impact in our phase III trial in patients with this indication in 2024 and then the final analysis in 2025.
This study is the first and only phase III in myelofibrosis trial with overall survival as the primary endpoint.
And thus represents great potential value for patients as well as for our shareholders.
Achieving these milestones requires the motivation and expertise of each year on team member their continued dedication and commitment inspire me every day.
With that I'll turn the call over to our Chief Medical Officer, Dr. Pei filler for a clinical update.
Thank you chip and good morning to everyone on the call.
We are incredibly excited that the topline results of the emerge phase III study in lower risk Mds are just two months away.
The clinical team has been actively preparing for the readout in accordance with industry best practices.
The clinical cutoff for the top line results occurred last month, which per protocol as one year. Following the first dosing of the last patient randomized in the study.
Have been continuing database cleaning activities and monitoring visits with our clinical sites in preparation for database lock, which is expected to occur before the end of the year.
In early January 2023, we expect to deliver the phase III emerge topline results.
Which will comprise a robust package of data that we believe will highlight the differentiating qualities and the <unk>.
I'll start.
We anticipate sharing data on the primary endpoint of eight week transfusion independence or Ti.
As well as key secondary endpoint of 24 week Ti.
And hematologic improvement erythroid or H I E.
Which is a composite measure of the percentage of patients who experienced an increase in hemoglobin and or a reduction in their transfusion burden.
We also plan to provide safety data in order to give a balanced benefit risk profile of Intelsat and lower risk Mds.
As is typical for a phase III trial top line results represent only a portion of the full clinical study readouts.
And we anticipate to present more comprehensive results at a future medical meeting.
We expect the later additional data will include information on molecular indicators of disease modification, such as mutational burden reduction.
And in effect onsite a genetic abnormality.
The phase III emerge trial design matches, many of the elements I would say too.
Including clinical site location and investigators.
Patient population and enrollment eligibility criteria in.
And the tests that dosing schedule primary and secondary endpoints.
And other protocol specified guidelines.
Given such similarities we believe the phase II results will help inform us on the phase III.
As Tim alluded to in our comments. This morning on Sunday December 11th longer term follow up data from the emerge phase two study will be presented in an oral presentation at ash this year.
The abstract for this upcoming presentation published this morning as summarized on slide nine.
Our Q3 earnings call back and is currently displayed on the webcast for those watching.
The abstract describes the 29% of patients in the emerge phase II study.
<unk> sustained transfusion independence for greater than one year in the setting of a median pretreatment transfusion burden of six units of Red blood cells over eight weeks. We believe this to be an unprecedented durability effect in patients with lower risk Mds post Esa treatment.
These 11 transfusion dependent patients were treated with <unk> for a median of approximately two four years and their median duration of Ti was one eight years.
After a median follow up of four three years medium progression free survival was $2 nine years and median overall survival was four eight years.
None of these patients progressed to AML.
Mutation data was available for the majority of the patients who achieved greater than one year sustained ti.
And 89% had any reduction in S. F. <unk>, one variant allele frequency or vas on.
56% achieved greater than or equal to 50% the EIF production.
Reduction in D E F correlated with longer Ti duration, and shorter time to onset of Ti.
We believe these data along with our long term fiscal OPI indicate strong evidence of disease modification.
Safety findings for these patients were consistent with the overall population and.
And the most frequent adverse events were reversible thrombocytopenia.
And neutropenia.
The abstract concludes at the greater than one year periods of transfusion independence observed in these patients represents relief from iron overload and other transfusion associated complications.
A decreased demand on health care resources.
Furthermore, durable ti meaning.
Meaningful reduction in mutation burden.
And good survival post Esa suggest them Intelsat may have disease modifying activity.
Recent data as well as the prior publications of emerge phase two data reinforce what we believe are key attributes of <unk> and lower risk Mds.
First we observed durability of continuous transfusion independence, which we consider differentiating from any treatment currently on the market or being investigated today.
Second broad efficacy was observed across patient subtypes, including Rs positive Rs negative high and very high transfusion burden patients.
Third there was strong evidence of disease modification.
As described previously by chip that due to <unk> unique mechanism of action aims at the very nature of the disease Mechanistically.
And that has not been previously observed with other treatments for that patient population.
Moving onto myelofibrosis.
There are two posters being presented at Ash this year for our current and massive trials in progress.
As many of you know abstracts focused category describe innovative envelope ongoing clinical trials that have not yet reached the primary endpoint.
The first trial and progress abstract describes our pivotal phase III impact study, which is designed to enroll approximately 320 patients with relapsed refractory in myelofibrosis.
<unk> is the first and only phase III trial with overall survival primary endpoint.
Approximately 85% of clinical trial sites are open today and.
And we remain on track to open also elected clinical sites by the end of this year.
Our current planning assumptions, we continue to project the interim analysis for impact MF will occur in late 2024.
Of course.
Because these analysis are event, driven and it is uncertain, whether actual rates for enrollment and rates for events for <unk>.
<unk> current planning assumptions the results of the interim analysis may be available at a different time than currently expected.
The second trial and progress abstract accepted at Ash describes improve on that which is our phase. One study designed to evaluate the safety and clinical activity of <unk> in combination with <unk> in patients with frontline <unk>.
This study design was informed by preclinical data that showed that sequential treatment with <unk> followed by <unk>.
A selective inhibitory effect on malignant and <unk> stem cells, while sparing normal hematopoietic stem cells.
In this clinical study, we expect to determine the safety profile of combination therapy.
And explore any potential for disease modifying activity in a frontline MF disease setting.
Similar to what was observed with <unk> treatment in the phase two embark trial in a relapsed refractory MF patient population.
Two of the three trial sites for the study are open for patient enrollment.
We expect to present preliminary data from this study by the end of 2023.
As part of our <unk> pipeline expansion. We are also exploring use of the drug in other indications in combination regimens.
At Ash this year additional non clinical data related to acute myeloid leukemia or AML will be presented.
The abstract for the upcoming oral presentation describes the results from non clinical in vitro and in vivo experiments with <unk> using AML cell lines in AML patient samples.
Conducted by our collaborators in Australia, Germany, and the U S. The experiments found that <unk> that promotes the formation of poly unsaturated fatty acid containing phospholipids.
Which cause excessive level levels of lipid peroxidation and oxidative stress in AML cells potentially leading to programmed cell death.
The abstract concludes that this mechanistic insight could be leveraged to develop an optimized therapeutic strategy using oxidative stress inducing chemotherapy to sensitize patients to <unk> and potentially cause significant delay of relapse in AML.
Based on these and other non clinical data in AML as well as the clinical data we have in lower risk Mds. We are supporting an investigator led study called Empress in relapsed refractory AML and higher risk Mds.
In that study and Intelsat is being evaluated as a single agent.
We continue to expect the first site to be open for the study by the end of this year.
Meanwhile, we have another investigator led study in relapsed refractory AML named Taylor Mirror.
In this study we plan to evaluate <unk> in combination with a hyper methylated agent and in combination with <unk>.
This study has been deferred until we have data from the impressive single agent study in relapsed refractory AML.
We expect data from Empress to help inform the dose and schedule to be used in the two combination dosing regimen that will be evaluated and tell them here.
The principal investigators for both studies continue to be highly enthusiastic.
Relapsed or refractory AML remains an extraordinarily difficult malignancy to treat.
They believe a new mechanism of action from a drug like <unk> that that directly affects the malignant progenitor cells that drive disease progression could provide an effective treatment option for patients suffering from relapsed refractory AML.
Also in keeping with our pipeline expansion activities.
New non clinical data.
With <unk> and lymphoid malignancies will be published online in blood.
Abstract describes the characterization of telomerase activity and telomere length.
And results from in vitro experiments of <unk> on a panel of diffuse large b cell lymphoma.
D L B C L.
And peripheral T cell lymphoma, or PTC ALS outlines.
Conducted by our collaborators at MD Anderson Cancer Center.
These in vitro experiments demonstrated that in hotels that reduce cell viability and increased a pop to assist.
In D L Bcl cell line.
In contrast, <unk> single agent activity on cell viability was limited and P. T C. L cell lines, even though a time and dose dependent reduction of telomerase activity was noted.
The greater inhibitory effect of the metals that in D. L. B C L compared to P. T. C. L may be attributed to the observation of higher telomerase activity in D. L. B C L compared to PTC all cell lines.
Furthermore, the PTC all cell lines had an approximately seven three fold longer kilometer lengths than the <unk> lines, which potentially also influenced the lower response to Intelsat.
We expect further experiments to be conducted to explore these insights and to assess the potential therapeutic effect.
It helps that in lymphoid malignancies.
Finally.
I am pleased to report that we are making progress in our next generation telomerase inhibitor program from which we anticipate generating lead compounds for further characterization and devaluation way.
We anticipate completion of the current discovery effort in 2023 upon which we plan to potentially advance any lead compounds into the next step of discovery research.
If successful these efforts would permit initiation of IMD, enabling non clinical studies.
Overall, I am delighted with the progress of the research and development team both with regards to advancing critical activities for our lead indications in lower risk Mds and relapsed refractory myelofibrosis.
As well as our pipeline expansion programs, which aim to understand the broader potential of them. It helps that.
With that I will turn the call over to Olivia for a financial update Olivia.
Thanks, Jay and thanks to everyone on the call for joining us today.
Please refer to the press release, we issued this morning, which is available on our website with detailed financial result.
As of September 32022, we had approximately $195 million.
Cash and marketable securities.
This includes approximately $4 million and proceeds from warrant exercises that we received this quarter.
Overall operating expenses or fire prevent three and nine months ended September 32022, compared to the prior period, which reflects increased activity across the company.
As well as accounting for the recent settlement agreement related to the class action lawsuit.
On the R&D side.
Increase in expenses for the three and nine month periods of 2022.
Compared to the same period in 2021.
Primarily reflects the net result of.
Increased personnel related expenses for additional head count.
And higher consulting costs.
Related to preparation for topline results and.
And regulatory submission in low risk Mds.
Which were partially offset by decreased manufacturing call due to the timing of <unk> manufacturing batches.
On the G&A side.
The increased expenses for the three and nine months period of 2022 <unk>.
Compared to the same period in 2021.
Primarily reflects.
Increased costs for commercial preparatory activities.
Higher personnel related expenses for additional head count.
And an accrual of approximately $7 million for our portion of the settlement for the class action lawsuit.
Which we expect will be paid in either shares of John common stock.
Our cash.
At our election.
After final approval of the settlement by the court by the end of the first quarter of 2023.
We continue to expect non-GAAP total operating expenses of up to $150 million for the full year of 2022.
Under our current planning assumption, we expect to have approximately $140 million in cash and marketable securities at the time of the law with MDF topline results in early 2023.
We also expect to have.
Up to $171 million in.
<unk> funding available to us in 2023.
Which is comprised of approximately $121 million from.
Exercises are currently outstanding warrant.
And an additional $50 million from potential debt drawdown under our current loan agreement upon the achievement of certain milestones and capital requirement.
Under our current planning assumptions, we project, our existing capital resources, plus the projected future proceeds that I just outlined will be sufficient to fund our estimated levels of operation which include integrated activity for potential U S. Commercial launch and that's helped that.
Low risk Mds.
Till the middle of 2024.
With that I will now turn the call over to chip for closing remarks.
Thanks Olivia.
As I indicated at the start of this call we're on a journey towards becoming a leader in the treatment of hematologic malignancies.
On this journey, we expect to achieve very meaningful milestones, which we believe will not only move the company from clinical development toward commercialization.
But also potentially change the treatment landscape for lower risk Mds and relapsed refractory MF.
Thank you all for your interest in the company and support for our continuing activities, we'll be glad to take your questions.
At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
Again to ask a question press star one on your telephone keypad to withdraw your question Press Star one again, a little pause for a moment to compile the Q&A roster.
And your first question comes from <unk> <unk> from B Riley. Please go ahead.
Okay.
Thanks for taking my question. So there was a positive announcement earlier this week.
From Bristol Myers Squibb regarding the command study.
Testing was better served in the frontline setting for Mds.
Yes.
What implications if any does this have on your potential path for <unk>.
I think your trial is enrolling patients who have received.
It looks better 74, so curious if you see or foresee any shift in how <unk> may be used in the real world assuming the phase III is positive.
And then does it change anything from a regulatory perspective as well. Thank you.
Yeah.
Okay.
And to note.
It does start to <unk> phase III trial does include patients who are previously treated with the spud to spud.
We expect them it does start to become part of the standard of care in low risk Mds and can be broadly adopted for their treatment of obese patients with very high unmet medical need.
We'd also like to remind all of us that we had multiple other patient subtypes that blood eligible for this trial irrespective of data inside of <unk>.
This included heavily transfusion burden, Esa relapsed and refractory patients and also frontline Esa ineligible patients given their high baseline.
What levels.
As chip.
Said in their prepared remarks, we expect them or does it start to be highly differentiated given our distinct mechanism of action that targets in case, the malignant stehman progenitor cells and allows for the ability to Marty part of their disease and achieve continuous and highly durable transfusion independence rates this data which is <unk>.
Reported in today's Ash abstracts.
Directly addresses significant unmet medical need in low risk Mds and we expect it to be very favorably received by the physician community.
Also want to remind everyone that from a commercial perspective the market in Mcdonough started addressing is highly attractive.
And approximately three times larger than the patient group indicated under the current <unk> label, which is limited to Rs positive patients, we expect broader adoption and remain confident that watering rental car days are addressing is truly to these marty fine and we expect broader adoption. So I'll just stop here.
Okay, and one question on the emerge readout coming up in January .
What level of detail should we expect on some of the secondary endpoint.
Maybe the one year.
Ti rate and some of the other endpoints there.
I think you should expect the secondary endpoints.
Would include of course, the 24 week.
Ti.
And obviously all of the safety data as well as the primary endpoint say any other comments.
But at <unk> as well.
Okay.
Shouldn't see any one year.
<unk> rates there.
The phase III Readouts.
Not sure.
Okay, alright, thanks for taking my questions.
Your next question comes from Steve <unk> from Stifel. Please go ahead.
Yes. Good morning, Thanks for taking my question.
I guess.
Maybe just following up on the on the topline disclosure in January .
I was just curious if we should expect to see any specifics.
Sure.
Any specific efficacy data within certain subgroups of interest and I guess, the subgroups would be.
Those patients who have a <unk>.
Very high transfusion burden at baseline maybe.
Serum <unk> levels with greater than 500.
Is that something that you think will be seeds for future presentation or is that something that we could see a topline press release, just kind of giving.
Given the importance of that from a competitive differentiation perspective.
Thanks for your question I'll take that yes.
Yes, we will have subgroup analysis at the time of DLR, we will provide additional.
Data of course at a major medical meeting subsequently.
Okay. That's good to know and then.
Maybe just a question on improved on that.
I guess when you look across the competitive landscape.
It kind of seems like.
There is an effort to combine.
Sure.
Various agents with rocks that actually address some of the anemia that is caused by rocks.
And just curious just given I think in my speech to embark study there was a bit of an anemia signal from them to tell us that.
How do you just think about the notion of.
Exacerbating the toxicity that.
It is.
Across the competitive landscape.
Fair enough.
Yes.
Yes.
Hey, you want to comment about that study sure. The improve MF study is as you say our combination study in frontline patients roughly nib and even help that and the primary objective of that study will be to assess.
The safety profile of the combination therapy, including any potential cytotoxicity cytopenia.
The main objective.
We're not 100% sure what we're going to see and that's why it's really a safety study as opposed to primarily an efficacy study, we'll obviously look for efficacy.
Signals.
And.
Of course, the paradox here is that we know that we have.
In the phase II data certainly very strong.
<unk> response is positive in EMEA responses and so I.
I think.
We will just have to see how it works out, but I think we'd be.
Well.
The real focus of this is indeed getting a safety look.
<unk>.
Okay.
And then just lastly, I guess on <unk>.
Packed MFS.
Congrats on getting a lot of that.
A lot of the sites opened.
How should we think about.
The manner in which youre going to be communicating.
Enrollment milestones.
Or is that something that you will not be providing.
Go ahead, and I guess, I'm, just thinking about whether or not we hear as too.
The patients have been enrolled.
We're just very small things like that.
Yes, historically, Steve we've communicated.
When we hit 50% enrollment, we'll probably do that with this study as well of course I would want to remind everybody that.
Because this is an overall survival study and its really event driven the specifics of the enrollment kinetics. While they are certainly linked to that you can you can have events and less people are enrolled at the same time.
They're not.
We're not on a hard.
Schedule of events, where we're enrollment completely dictates when results come. So we still currently expect the interim analysis in 2024.
Okay. That's helpful. Thanks for taking the questions.
Thank you.
Your next question comes from Joe <unk> from Needham and company. Please go ahead.
Hi, everyone. Good morning. Thanks.
Taking my questions as well so maybe a quick one on the oral presentation. The long term follow up of the merger kind of struck me about.
Some of the details you provided there looked a lot like what you saw in that.
Regarding the reduction.
Production of specific loans, so maybe a longer term thought is there any reason to consider making an overall survival outcome study.
MBS at some point thank you.
Yes.
Sorry, just to make sure we understood. The question, we were having a little bit of trouble hearing you.
Could you.
No.
Overall survival obviously.
Thank you were trying to relate.
The question about overall survival in long term follow up of Mds did I get that right.
Yes, that's correct.
The results would look a lot like what you saw in myelofibrosis on a molecular level.
So you want to comment on that sure thanks for confirming.
So overall survival. In addition to progression free survival of both secondary endpoints on the myeloma Myelodysplastic syndrome study emerge.
We will be looking closely at that.
Okay excellent.
And as for the <unk>.
Combination studies.
In AML.
Yes.
Preliminarily youre going to first Luca.
The single agent activity, and then add combinations on top of it but how do you see that.
Kind of the evolving landscape.
Initially the goal of the combination studies in AML is evolving into <unk> and have been actually always treated with combination therapy and multiple approaches, especially in the frontline setting.
As we.
And investigate the safety of the combination therapy in the <unk> study, combining with either <unk> or <unk>.
In addition to the safety of course be looking for any preliminary signal of efficacy.
Yes, there is that clear.
A clear need for a novel mechanism of action.
That works differently than the currently available therapies in AML and especially.
In relapsed refractory AML.
Alright, Thank you for another clarification and thanks for taking our questions.
Sure.
Your next question comes from Joel Beatty from Baird. Please go ahead.
Hey, good morning, Thanks for taking my questions. The first one.
On the phase III Mds trial could you emerge could you discuss the.
The SMB reviews that have taken place.
Throughout the study and recently in.
Anything learned about safety there.
We have.
Thank you for your question, we have an independent data monitoring committee in place for the study who review the unblinded safety data and to date. They have continued to recommend the study proceed.
As indicated they meet on a regular basis.
Great and then maybe just one thing.
Terrific. Thank you.
Question on the command study.
Whenever we get more data on from BMS could you discuss what data points you'd be and I'm curious to look for.
I can take that question first Jonathan obviously.
Bacon add onto it so one of the more important things in low risk Mds, especially for patients who are predominantly anemic.
Continuous and highly durable transfusion independent states.
And in all our market research from clinical and scientific forums and discussions with our advisors. This remains a high unmet medical need.
There is significant dissatisfaction in this market being expressed with agents that have been currently approved and have existed Bobby armamentarium for physicians, who treat this disease. So we would look for the quality of data that durability of Ti.
And various subgroups and adoption is dependent on all of those things, but I also on beauty you state one more time.
We target the malignant stem and regenerative status and when it does start has the ability to modify the disease and what we are seeing in our phase two data is highly encouraging in terms of continuous and beautiful transfusion independence and high transfusion burden patients so the value proposition for them and does it start.
Sure be ready very strong.
But obviously, we would be curious to see what happens in the frontline settings.
Okay anything to add from your side I would add to that that I'd be interested to see not only in <unk>.
EMEA improvement and improvement in hemoglobin, but the.
The amount of transfusion burden reduction, especially as you mentioned in the on a continuous.
Basis in that study.
Great. Thank you.
Thanks, Joe.
Your next question comes from Vernon Bernardino from HC Wainwright. Please go ahead.
Okay.
Good morning, everyone and thanks for taking my question.
Thanks also for the update on the phase III impact MF trial.
That's good.
Good progress I'm curious about the.
Improve MF phase one trial in frontline myelofibrosis.
I think if I remember correctly. The study is being conducted in three so just wondering how enrollment is progressing in that study and then also.
Thank you mentioned.
The presentation of.
Thank you very much.
Part one or.
Some of the data.
Just wondering.
As far as the optimization of dose in part one of the study with Russell Goodman.
What are your expectations as to how long those patients would be on Russell Lids and then in the.
Phase two part.
Ill.
What is that patients are not able to tolerate at.
At least <unk> of Brookfield.
That study may be conducted.
Completed thank you.
Sure. Thanks for your question I'll start with the first one first regarding the enrollment.
Correct that we have our plan for three sites to be open currently two of those are open.
This is a dose escalation.
Study, we are proceeding with enrollment at.
Expected.
At the various dose levels.
We do.
And the next question was regarding <unk>.
<unk> and how long, we anticipate patients Amdocs, Linda and I think that is one of the questions that the trial will answer and intends to answer of how.
How long a combination therapy could be tolerated and.
Whether there are options for.
Single agent treatment as well.
Okay just to follow up then what kind of preliminary data might we expect in <unk>.
2023 from program Max.
We anticipate preliminary.
Lefty data.
Yes, I think it's mostly related to safety, obviously, if we see interesting efficacy signals will probably talk about that this is.
This is an early.
Early.
The early phase study. So we can do that but we'll have to see how it works out. It is a it's an open question of whether the two drugs will be able to be <unk>.
Combined we.
We have.
Great Hope and then obviously, where it is is the dose go and so it is a dose finding study as Jay just said Thats a critical element of it as we escalate dose.
Okay. Thank you for taking my question.
Very interested in the frontline plus.
Possibilities of Intelsat.
Thank you.
Thanks Kurt.
There are no further questions at this time I will turn the call back over to Erin Feingold for closing remarks.
Thanks, so much everyone for joining us today and for your questions. We really appreciate you taking the time to dial in and participate.
Thank you.
This concludes today's conference call you may now disconnect.
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