Q3 2023 Onconova Therapeutics Inc Earnings Call
Ladies and gentlemen, thank you for standing by.
Welcome to only turnover therapeutics third quarter 2023 financial results and business update conference call.
At this time all.
Participants are in a listen only mode.
Following managements prepared remarks, we will hold a question and answer session.
To ask a question at that time fish fresh star followed by number one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this call's being recorded today November 14 2023.
This time I would like to turn the call over to Bruce Mcevoy lifestyle advisors.
Yes.
Thank you operator, and welcome everyone to lock in Otis third quarter, 2023 financial results and business update conference call.
Earlier this afternoon <unk> issued a press release reporting its financial results and business progress. If you have not yet seen this press release. It is available in the investors and media section of the company's website at www dot on kind of a dotcom.
Following my introduction, we will hear from <unk> is president and CEO, Dr. Steve Fruchtman.
Chief Medical Officer, Dr. Victor <unk>, and Chief operating Officer, and Chief Financial Officer, Mark Guerin.
I can <unk>, the VP of global Medical Affairs, and research and development Mina Aurora will also be available during the Q&A session. Following the prepared remarks.
Before we begin I would like to remind everyone that statements made during this conference call will include forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially.
Forward looking statements speak only as of the date. They are made as the underlying facts and circumstances may change, except as required by law on kind of a disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
For more information on forward looking statements. Please review the disclaimer in today's press release and the risk factors in the company's SEC filings.
With that I will now turn the call over to <unk>, President and CEO, Dr. Steve Hoffman.
Yeah.
Thanks, Bruce and thanks to everyone, who is joining us today for this call.
Okay.
Saying that I think in November has made excellent progress.
Third quarter <unk> 20, each week.
During the call today, Alright, Chief Medical Officer, Dr. Victor Mario.
<unk> operating officer, and Chief Financial Officer.
Oh good.
I will.
Why you Wouldnt update when a.
Our lead program.
We view the data.
Scientific presentation.
Oh boy.
Milestones.
To provide a brief update Vega.
I'd been program.
Yes.
Our third quarter financial results.
And our cash runway.
Thanks.
And of course importantly, open the call for your questions.
As you know.
It.
Remains to develop novel try of dairy products.
With hard to treat cancer.
Okay.
Eight.
Starting with our lead program.
In general average dedicated.
Okay.
Operations.
Right.
Okay.
Okay.
Okay.
Alright six.
And each other.
Alright.
So growth and DNA synthesis.
The CDK four six class a inhibitory drugs.
Change the face of cash a cure in several indications.
Homeowners.
Homeownership depositor.
<unk> negative metastatic breast cancer.
As you cycle it was designed by <unk>.
Science is a potent next generation engines.
James.
A multibillion dollar drug class.
In addition to its most economies activity.
We believe.
It may be differentiated from the weather.
PDK for us.
You gave for <unk> inhibitors.
Of course the protests.
Sure.
True Tolerability profile.
Based on our preclinical studies.
<unk> efficacy as well.
The ability to target to act on targets.
CDK four and six may lower the risk of drug resistant.
There is other CDK <unk> inhibitors.
Our expansive preclinical studies have helped to define their address site.
Hey.
Two impact on additional vital targets involved in cell signaling.
Cancer survival.
Excluding the proteins arc five also known as new at one <unk>.
CSF, one hour and Bob one.
All important and how cancer establish hits its presence.
Ann.
Sites of metastatic disease as well.
As proliferation of the cancer cells.
We have select low grade endometrial endometrial cancer.
B our lead.
Just duration indication for neurology cycling in combination.
Hormone therapy.
Yes.
We believe this is the right choice.
Endometrial cancer for two main reasons number one.
Power's registration or trial.
Hi Tech technical and regulatory success success probability of success.
Publication or positive studies.
Other CDK four and six inhibitors and next year's all combinations and compendium of data, indicating off label use.
Toward the potential.
Alright, well high probability of technical success.
These data and <unk>.
Correct.
An approved label.
Score unmet.
Unmet medical need and support the potential for regulatory success.
The second reason is the initial data from our dose ranging study suggest.
This site has the potential to be safe.
Did you get it for six approved inhibitors.
Why dosing window.
Excellent.
Index.
Note that during our call today.
We may use the acronym al Geek to describe this indication and endometrial endometrial cancer.
She'd be Registrational trial.
We plan to one.
Dose escalation segments.
Our phase one two programs.
Define a recommended phase two dose or <unk>.
T D.
Secondly, engage with the FDA on the <unk>.
It'll trial design.
The construction.
Number three.
With key external clinical experts on the design and conduct this trial.
Including the gynecologic oncology group or <unk> and.
And the European network for Gynecologic oncology trials for <unk>.
Our plan is to conduct a registration trial as part.
In collaboration with.
Both of these very prestigious groups.
We intend to provide more information on each of these steps over the next few quarters.
As you know there are three early stage studies underway and then their address and program, including monotherapy and combination.
Trials.
Given <unk> multi kinase mechanism of action.
We've conducted dose escalation studies very carefully.
Well Victor or summarize the status of these studies based on the clinical and biologic biological target engagement.
Acceptable overall safety, we are observing we have decided to dose escalate.
One more dosing cohort to fully evaluate the safety profile.
<unk> cyclic.
Zhiji optimal recommended phase two dose.
As a result of the phase one two program.
The cycling.
They continue into the first quarter of 2024.
We believe this is very good news.
Broader program because it underscores the potential for an <unk>.
A differentiated safety profile and a wide therapeutic index.
Changing gears.
I would like to touch briefly on our second program that is rigorous narrative.
As you know in keeping with our focus on capital efficiency.
We have been exploring the clinical utility of these asserted brewery serious signal finding investigator sponsored trials focused on solid tumor indications driven by legal shortage impact.
One of two mechanisms.
First is the P. Okay, one pathway involved in squamous cell carcinoma complicated recessive dystrophic Epidermolysis, what was there and the second mutated cash.
<unk> and K Ras mutated non small cell lung cancer.
In combination with checkpoint inhibitors.
As outlined in our second quarter call.
We're focused on mapping out a registration study plan.
Ultra rare indication of Ardeb associated.
Squamous cell carcinoma.
Note that we would define that as idea of associates.
In this call.
We selected this to be the lead Registrational indication based on the very impressive clinical responses, we have seen to date in previously refractory patients.
And with the significant unmet medical need.
This desperate patient population.
As you know we had a type b meeting with the FDA in June.
Based on this meeting and feedback from the agency.
As outlined in our second quarter call.
Ken to develop a protocol for a registration or trial.
Following interactions with the rare disease group at FDA in pursuit of an orphan designation for <unk> debit associated squamous cell.
Plan to provide an update on next steps in the first half of 'twenty 'twenty four.
Looking ahead to the rest of this year and into 2024.
Focusing on achieving the following milestones.
As you say, we intent one.
Continue the dose escalation segment of the phase one two program.
<unk> and which may bring us into the first quarter of 2024. So we can add at least one more dosing cohort to this study.
To provide a readout on the site and safety and pharmacology and the first half of 'twenty 'twenty four once we have completed the dose escalation studies.
Number three.
Update on our Registrational trial readiness over the next couple of quarters, including the definition of the recommended phase two dose.
Alright engagement with the FDA and the pivotal trial design and obtain a rare disease indication orphan disease indication and I'll work with internal and external clinics.
Experts, including the Georgi Andi.
Achievement of these milestones will also enable us to establish a solid foundation to.
To expand the program to include other indications.
Cancer and ovarian cancer.
Well, we got assertive as I just noted in the first half of 2024, where you continue to plan to provide an update on the next steps to obtain orphan drug designation and from a Registrational program.
Before I hand, the call.
To warmly congratulate Victor.
Are you taking on the role of Chief Medical Officer and warmly welcome.
Aurora.
Vice President of Global Medical Affairs Research and development.
Victor and I previously worked together at J&J.
He was instrumental in getting approval for some of the most revolutionary and impactful drugs in both supportive care and hematology oncology.
Both of them are accomplished experts in their fields and.
Bring significant and why is that.
Experience in drug development.
I believe his extensive track record as a clinical researcher in drug development in oncology.
Millions of unique medical affairs expertise in rare diseases, and oncology will be instrumental to the company's success as we prepared the clinical plan and regulatory strategy.
As a cyclist and we got startup.
Now I would like to turn the call over to Victor to provide some more details on in a RASM effect on program they start.
Okay.
Thank you, Steve and good afternoon, everyone.
Today I'd like to.
<unk> you with an update on the night, rather cyclic phase one two program.
And touch briefly on our recent and upcoming medical meeting presentation.
That's in with the rest of the cycle.
As you May recall there are three.
Sadly in the phase one two program in advanced.
The solid tumors in patients.
The phase one monotherapy dose escalation study underway with our partner Hynix in China.
Is there a phase one monotherapy dose escalation study underway at three centers in the U S.
A phase one two combination dose escalation and dose expansion study, which is underway at six centers in the United States.
This study is evaluating the combination of increasing rather the cyclic doses and a fixed.
2.5 milligram per day dose of the widely prescribed anti estrogen agent Letrozole.
This study has been conducted in patients with L Inc.
And Ah Ah Ah Ah gynecological tumors, we're undergoing second and third line treatment.
As of November 13, 2020 are clean we have dosed about 30 patients across the entire phase one two program.
In the U S phase one monotherapy study we are dosing patients in the seventh cohort at 280 milligrams per day.
Yes.
In the phase one two combination study we are starting the second cohort at 200 milligrams per day of net rather sites with two five milligrams per day of Letrozole and have identified patients who could enroll them.
On the next cohort.
Based on the data we have observed to date, we have three important initial observations.
Number one there.
And there is a site that is safe and well tolerated to date.
Like to make two points about the emerging safety characteristics of sidekick.
First based on the initial safety data.
Okay, let's extending it may be possible to dose la Raza once.
Once daily without the need for time off during treatment.
This is important because it may address.
And all they.
The need for a three week on and one week of dosing strategy that is required for bone marrow recovery.
During treatment with the most commonly prescribed CDK <unk> inhibitors.
We believe this is an important potential feature or not rather say too because the requirement for three weeks on one week off dosing strategy may also permit to myself proliferation in between.
Dosing.
Secondly, initial data for our from our dosing studies suggest that no other things that may be able to avoid the difficult adverse event of diarrhea.
We believe that these two distinctive characteristics may enable a wide dosing window that support an excellent therapeutic index when I arrived on site.
Number two we're seeing target engagement based on the observation of grade one and two neutropenia in patients receiving a dose of at least 120 milligrams per day.
Number three we are seeing.
Biological target engagement based on the results of the Diamond in Cagny I see at doses of 200 milligrams and above.
As indicated by Steve based on the good target engagement and overall safety that we observed and we believe that it would be reasonable to dose escalate to at least one more dosing cohort.
To fully explore the safety profile of the sites and to enable us to achieve the optimal recommended phase two dose.
This will extend the phase one program for La Raza, thank slip into the first quarter.
I would like to Echo Steve's comment that our decision to add at least one more dosing cohort to the dose escalation study is very good news for the program because it underscores the potential for that as a cyclical.
Have a differentiated safety profile and wide therapeutic index.
We expect to provide a readout on safety and pharmacology and the first half of 2024. Once we have completed the dose escalation study.
This approach will help define the optimal round a recommended phase two dose and we believe it is also in keeping with the FDA guidance from project Optimus for dose optimization prior to approval.
Also in the third quarter there were two.
Medical meeting presentations related to our programs.
This included a presentation.
Number one of clinical data affirming the potential for Regal said to in our Deb associated squamous cell carcinoma.
Suppose made by our colleagues from the University Hospital in Salzburg, Austria, and Thomas Jefferson in Philadelphia.
Yeah.
This data were presented as a late breaker at the European Academy of Dermatology and neurology.
Mhm.
The second presentation.
Of promising preclinical data in combination with the.
Of note the cycling in combination with it broadly in the treatment of.
Sensitive and resistant mantle cell lymphoma cell line was.
Even at the European.
C L or mantle cell.
Net with lymphoma annual meeting.
Each of these are presentations underscore the biology and activity for now rather thick.
Rig was centered.
Looking ahead to December we plan to.
Present, two additional preclinical abstract the first one is the San Antonio breast cancer Symposium, often called S. A D C S.
One of our collaborators will present, a poster titled <unk> differentiate.
<unk> and kinase inhibitory activity contribute to the enhanced in the addition of tumor growth in preclinical model.
We have a second presentation at the American Society for hematology or Ash, where our collaborators will present, a poster titled Narrows the cycle.
<unk> differentiated CDK four six antagonist.
Hello cell cycle arrest and metabolic reprogramming.
Enabling risk duration of you broaden it sensitivity in PTK I resistant mantle cell lymphoma.
We will share more of these abstracts in the coming weeks.
In closing I am optimistic about our programs, our progress and the outlook for rig site and the other thing in.
In 2024.
For our regular says the promising activity that we have observed in our Deb associated square myself.
<unk> is distinct and could address a critical medical need for this ultra rare condition.
This data plus its unique activity on P. L. K, one and K Ras pathways make rigorous set of a very interesting anti cancer agent now that we have better define the indications where we believe.
We will be more likely to be.
The successful based on its mechanism of action.
And studying cancer as way of these targets can be engaged by rigorous it.
Yeah.
So now let's face it.
CDK four six inhibitor they are substantially changed the face of cancer for the better.
Consistent positive clinical data on the class in endometrial cancer.
In addition to target engagement our program is showing a acceptable initial safety, which could give narrows the sites at a unique profile.
Based on our expensive lives preclinical studies, we have defined a multi kinase profile.
That enables.
That could result in differentiated activity.
And the potential for broader clinical utility.
These features are the cornerstone of my enthusiasm and optimism.
Optimism for <unk> with that I'll conclude my portion of the call and hand, it off to Mark.
Yeah.
Thanks, very much Victor and good afternoon, everyone.
I'm going to have a close in the third quarter of.
2023, with cash and cash equivalents of $25 $2 million compared to $38 $8 million as of December 31, 2022.
Just on our current projections, we believe our current cash position will be sufficient to fund our ongoing clinical trials and business operations into the third quarter of 2024.
Research and development expenses for the third quarter of 2023 were $2 5 million compared to $3 6 million for the same period in 2022.
General and administrative expenses for the third quarter of 2023 were $2 $7 million and this compares with $2 $1 million for the same period in 2022.
Net loss for the third quarter of 2023 was $4 $7 million or 23 per share on 21 million weighted average shares outstanding.
This compares with a net loss for the third quarter of 2022 of $5 4 million or <unk> 26 per share on 29 million weighted average shares outstanding.
Yeah.
The change in net loss in the third quarter of 2023 compared with the same period in 2022.
It was primarily a result of the timing of manufacturing batch production and clinical trial expenses, partially offset by higher general and administrative costs related to our AGM and the 2023 period.
From a corporate development perspective, we continue to actively engage in a range of discussions related to partnering opportunities to support the progression of our programs.
With my financial review complete I will now hand, the call back to Steve for his concluding remarks.
Thank you Mark.
In closing.
We are enthusiastic about the excellent progress.
Didn't may football matches.
Third in the third quarter.
We look forward to building on that progress.
Wrap up 2023 and begin the new year.
Looking ahead, we have.
Focus on achieving the following milestones.
Alright differentiated multi kinase inhibitor cycling, we intend too wide.
Is that two abstracts at the December.
Medical meetings.
We continue.
Continue the dose escalation segment of the Phase one program, which may bring us entering the first quarter of <unk>.
<unk> School.
Great.
The readout on <unk> and safety.
In the first half of 'twenty 'twenty four.
All right.
On an update.
<unk> III readiness over the next couple of quarters.
Putting definition of a recommended phase two dose.
Yes.
Asia with the FDA on the Pip.
Duration trial design.
And plans to work to continue.
External clinical experts and.
In the guidance.
Oh did you.
And the European network for granite.
Oncology trials.
Hi.
Our plan is to conduct a registration trial.
Part of our ongoing collaboration.
Both of these groups.
These milestones.
While a strong foundation.
On the next steps are there as I could.
In our geek.
With added potential indications, including breast cancer.
Gary can add.
Mantle cell lymphoma.
But when we got started.
Graham has realized an investigator sponsored.
Trash strategy.
With several solid tumor indications on the way.
Our main afternoon here.
We remain focused on.
The associated squamous cell carcinoma.
And we continue to plan to provide an update on our next steps to obtain orphan drug designation.
A registrational program and.
The first half of 'twenty 'twenty four.
And in closing.
I wanted to recognize diligent and dedicated work of our management.
Management team.
<unk> partners and invest in games.
And most importantly, as well as the brave and dedicated patients.
We anticipate in our clinical trials.
And the investment.
All of the investment community.
Florida Okay.
And very important.
We look forward to updating you.
Progress.
With that well begin.
In today's question and answer session.
Operator.
Ladies and gentlemen.
We wish to register for a question for todays question and answer session. You will need to press Star then the number one on your telephone.
If your question has been answered English to withdraw your request.
May do so by pressing the pound key.
If you're using a speaker phone please.
Pick up your handset or answering your question.
One moment please for the first question.
Our first question comes from the line of Charles.
<unk> from Guggenheim Partners. Your line is now open.
Hi, everyone. This is Edward on for Charles do at Guggenheim.
Maybe I have to start off with just a question on.
How your how the.
And there was a cyclic plus electrodes all combination how that trial is tracking and maybe when we could see potential initial efficacy data I think you've talked about in the past that with the at for data update at <unk>.
'twenty three so I'm, just wondering how youre thinking about that now.
Sure.
Would you like to take that.
Sure.
Yes, thank you for that question.
Right now we are still in the process of a dose escalation as both Steve and I mentioned, we are seeing in Hawaii that therapeutic index, requiring us to go to.
Two higher doses before we.
Before we go into expansion mode. So these are the this is that it will extend into.
The 'twenty 'twenty four as they've resolved as well along with the monotherapy study.
And just to add to it.
I want to remind everybody and yet improve CDK four and six inhibitors were approved that.
<unk> on response.
Prolongation.
Progression free survival and overall survival.
That CDK <unk> inhibitors are not cytotoxic drugs.
And all of them cause response.
Tumor proliferation.
This improvement hopefully in PFS and overall survival would you anticipate seeing in a registration trial.
Sure.
Great and then maybe just a follow up question if I can on the mono therapy dose escalation. It sounds like you have both deep.
<unk> opinion in the.
The thymidine kinase asked there I guess.
How much room based on at least on the PK PD characterization do you think you have to keep escalating do you do you think you still have them.
Room to gain efficacy by by escalating further how are you thinking about that.
Yeah.
Yes, ultimately to make his decisions Oh.
Or whether we've reached an optimal dose for.
For the phase two we would look at a combination of.
<unk>.
Safety and PK characteristics as well as the pharmacy dynamic.
Ah studies you do raise a good you do point out that since we might not see the same degree of neutropenia and.
Diarrhea as some of the other beautiful okay inhibitor as we will be focusing on data coming from the T. K.
Including the Tolerability of course, but as well as Pharmacodynamic.
Yes.
We have ahead to expand the last couple of cohorts and usually when you see that it would suggest that we are close to reaching what might be.
Really.
The optimal dose or maximum tolerated dose.
Yes.
Our next question comes from the line of Jimmy <unk> from Ladenburg Thalmann.
Please go ahead.
Good afternoon. Thank you for taking my questions and providing hustle update I have three questions on there is little cyclic than if I have time I'll ask one more on that program. My first question is has to a portion of course, one is what how many patients are we expecting to see data from the taste a portion of this.
Got it.
And the second part of the question is following up on the adverse question then do we expect to see any efficacy data and given your comments.
Ive on the PFS versus response rate then would you envision the data mature to show any clinical activities on the PFS.
Yes.
Yeah.
Your rash.
The second part of your question first if I may.
So without a control arm.
<unk>.
The PFS.
Powerbar.
Matches in breast cancer.
Page eight three months.
We're not going to wait three months.
So that should be part of this phase one study.
The purpose of the phase one is just clearly establishment of the recommended phase two dose should be the last one.
<unk>.
Distributions.
B.
Uh huh.
Since 12 months eight months 10 months wherever it may be is very hard to interpret.
Control on me.
In this patient population.
Oh really.
What does the site will be important.
In the nation.
Glad to.
Registration trial, which clearly will have control.
And we should be able to.
The combination of <unk> PFS to want to the control arm at the FDA.
<unk>.
Josh.
Sure.
So we really are.
Now you see some efficacy data.
Response, and again these are not cytotoxic jon's, but sometimes you will see tumor shrinkage.
<unk>.
Yeah.
The registration trial will be determined by both geocaching response overall survival.
Yeah.
Rather than response Dave.
I don't remember the first part of your question Yahoo. I don't know if I answered it would you like to repeat it.
Uh huh.
This was helpful. The first part was the safety portion of the study how many patients what are we going to see are we going to see any target engagement and other other analysis as well.
Okay, Victor I think you've had enough arrest could you take that please [laughter], yes, the the the phase.
Dose escalation portion will be is driven by of course, the number of call that out to make them and roll. So that is a variable number and we keep an approximation of where we might we might end up.
The phase two portion is.
Is slated to enroll up to 30 patients.
In the in that Phase Iia portion.
Thank you Victor My next question is on the safety profile, so having not die not as much or not high impact diarrhea, or neutropenia as Neal and the information that you mentioned, taking the one vehicle portion in the clinical setting is also need information what I just said.
You need to take to remove that from the portion of what what are the discussions like with agency. How are you going to move forward with that part.
Well.
First off we are still to have our discussions with the agency.
Right now what we observe in our system is that we add the dosing continuous.
And as long as that's safety is supportive for continuous dosing our recommended phase two dose will include continuous dosing and that would be the provide the basis of.
The discussions that we hold with the agencies subsequently.
So right now we're not holding at that adult.
We're not doing the three weeks on one week on that some of the CDK four and six inhibitor aptitude, we are dosing continuously.
That's very helpful. Thank you I'll I'll keep my or the question I will jump into queue to be mindful of others. Thank you. So much for answering my question.
Well thank you Robert.
Our next question comes from.
Joe Pat finish.
<unk> seen when run.
Your line is now open.
Hi, This is Josh on for Joe. Thank you for the update.
I had a question about the enrollment and how that's looking and the number of patients for the phase two study in for Rick has started and that Teekay I resent then pay rise non small cell lung cancer.
Okay.
Victor.
Yes, we are since the last update we enrolled three.
<unk> more patients.
That's that and we we are looking to have an update in terms of outcomes.
Subsequently.
Once we obtain a report from the investigator.
Alright, thank you firstly.
The narrows the cyclic trial in solid tumor.
Are you seeing any specific solid tumor indications.
More of a certain kind of course.
Or has it been pretty uniform across the solid tumor.
The monotherapy trial.
We have in <unk>.
Enrolls a truly diverse.
Set of us.
Patients with solid tumors and so there isn't a particular pattern in the mono therapy that I can describe is standing out Michelle Ah patients tended to be more on the G. I.
[noise] gastrointestinal.
Type of tumors, but there really isn't anything that stands out as being unique in terms of the patient population we have seen them.
Alright. Thank you. Thank you again for the update.
Okay.
Yeah.
Welcome.
Our next question comes from the line of Robert <unk>.
From noble capital markets. Your line is now open.
Yeah.
Since you're going to be doing an additional cohort in the neurons are cycling solid tumors what.
Is your projected start date for phase two at this point.
Sure.
Perhaps I'll take that Joe.
Great question Robert.
If we see additional counties in 'twenty two 'twenty three.
Oh boy.
We may be done it's not.
Again, we may go into the first quarter to establish the recommended phase two dose.
We can't meet with the agency until we know the dose.
The registration trial, we wanted to see the safety.
Thanks.
It has to go into the first quarter of 'twenty four.
I wish the recommended phase two dose of <unk>, we estimate.
The registration trial will begin in the first half of 'twenty 'twenty four.
Great endometrial cancer.
Okay and.
There are no deal fees.
And the cohort to be added.
Could you add another second cohort in 2024.
It's always hard to predict these things derivative compared to what we see regarding as Victor explained.
Dynamic marker.
At this time in Chinese Margaret you already see engagement and as we dose escalate more engagement.
We know we are engaging the client.
<unk>.
Stem cell proliferation.
He is a mild <unk>.
It really depends it also depends on the T. J maxx as we dose escalate as P. J.
Staying at.
Max level.
Need to dose escalate.
Those all of those things.
Alluded to go into the decision.
Are we done at 280.
<unk> 280, which means.
<unk> phase II.
The 240, we're seeing enough evidence attunity shape with target engagement with an action on Teekay LNG train 280 <unk>.
The recommended phase two dose so.
It's easier to answer that question with data and.
And hypothetically.
I answered it to the best of my ability.
Okay, great. Thank you very much.
Yeah.
Our next question comes from the line of changed Molly for Milan.
<unk> Global partners. Your line is now open.
Hi, Good afternoon. Thank you for taking my question. My question is on the rig asserted.
Getting the orphan designation I know that we've discussed before some of the challenges on that can you walk through sort of the steps you have to take to sort of get the rigor server sort of orphan designation and how the clinical trial plan.
Might look should you get that.
Sure.
And Mena.
Sure.
<unk> squamous cell expert.
It's pretty rare diseases would you like to take a crushing of how we introduced the concept.
Squamous cell to the launching new brands.
Yeah.
Nina.
Mainly is calling in.
The UK shoot the connection is lost.
If I may.
Did you go this is clearly an orphan disease right 60 to 100 patients per year.
Our debt.
In the U S.
One scream as Sean Dodge patients.
Communications.
On June <unk>. So clearly this is an orphan disease.
Our goal.
The auction grew.
Explain to ask why this is different.
Our core spontaneous squamous cell.
And shine damage claims.
Your friend, because one our Deb squamous cell develops it may teenage years early twenties Qingdao.
Damage squamous.
Launched in the elderly.
Damaged squamous very good prognosis, using a move strategically and actually ended with very big required alright.
Alright that squamous cell.
It's a very aggressive disease as I just mentioned.
Sure well known differentiates spontaneous screen themselves from my Dad's screens now distracted.
Squamous, Sean Complicating line.
Jason.
G spontaneous.
Danny screens.
Okay.
Do you often group is to explain why this is Dan.
Squamous cell the difference.
Carmen screens, which in fact is not it's not dry.
The definition of an orphan disease, but clearly IBM screen Michelle.
No H to interact with the agency to explain.
D J.
Yeah.
Apologies my line dropped and thank you for answering them.
I've got no certain things to other partners.
Hello, Ken.
And also.
Presented last month at the ATB meeting.
Late breaking abstract and we will be taking learnings from the initial patient experience and moving that into clinical development Registrational program as well and its discussion. So in addition to the discussion you mentioned about the orphan drug designation will be also doing my apologies my line dropped.
Thank you so much.
Nadir did change how much informed and I did only based on that change in my view.
[laughter].
Okay.
Thank you very much for that I guess, one follow up question would be is it is it more sort of a check check various boxes or do you have to go make a presentation and sort of pitch them in.
On the disease or is it just kind of wanted to fill out how does that sort of mechanically work.
Well basically doing anyway.
The integration group launches to hopefully to be changed.
Your action with that gets much more value.
The FDA.
Group will make that call.
We will request a face to face meeting my understanding has been doing most of these virtually.
And then maybe just respond to written racing bump on why we believe we deserve.
It's up to you.
Yeah.
Thank you for taking the questions.
Oh.
I'm showing no further questions in the queue, ladies and gentlemen, thank you for your participation in today's conference call.
Concludes today's Japan, you may now disconnect.
Thank you.
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