Q4 2021 Erytech Pharma SA Earnings Call
Welcome to the Erie Tech Business Update and Financial Highlights for the fourth quarter and full year 2021 conference call.
Good day, and thank you for standing by welcome to the Erie check business update and financial highlights for the fourth quarter and full year 2021 conference call.
At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. Please be advised, today's conference is being recorded.
At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised today's conference is being recorded.
If you require any further assistance, please press star then zero.
You require any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today CEO Joe Dan. Please go ahead.
Speaker Change: I would now like to hand the conference over to your host today, CEO Jill Billion. Please go ahead.
Jill Billion: Thank you, Michel. Good afternoon. Good morning. Bonjour à tous. Thank you for joining us for our business and financial update for the fourth quarter and the full year 2021 with key highlights and key financials for...
Thank you Michelle good afternoon. Good morning, Thank you for joining us for our business and financial update for the fourth quarter and full year 2021, with key highlights and key financials for.
Jill Billion: We announced our business and financial update on Friday evening, and the press release and the webcast presentation can be found on the Investors Relations page of our website.
For the year 'twenty one.
We announced our business and financial update on Friday evening in the press release and the webcast presentation can be found on the Investor Relations page of our website.
Jill Billion: Joining me on the call here today are Dr. Iman El-Hariri, our Chief Medical Officer, and Eric Sawyer, our Chief Financial and Chief Operator.
Website.
Joining me on the goal here today, our doctor email.
Our Chief Medical Officer and Eric.
Eric Soyer, our chief financial and Chief operating Officer.
Jill Billion: Before starting, and I'm on slide two of the deck, I would like to draw your attention to the disclaimer to remind you that today's course includes forward-looking statements, such as relating to the company's operations.
Before starting and I'm on slide two of them I would like to draw your attention to the disclaimer and remind you that today's call includes forward looking statements such as relating to the company's operations timelines and financials.
Jill Billion: And as you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially.
And as you know they'll evolve risks and uncertainties that could cause actual timing and results to differ materially.
Jill Billion: And now switching to slide three, the agenda for the call. I will, as usual, start with a short introduction and present the key.
Now switching to slide three the agenda political I will as usual start with a short introduction and presents the key highlights of the year.
Jill Billion: focusing on the more recent ones, the ones that occurred after our last call in November .
Focusing on the more recent ones the ones that are pure after our last call in November <unk> will then provide an update on the stages and the progress of our clinical programs after which we will come and will present, an update on our key financials and cash balance Hubert also summarize the strategic priorities and the expected timelines for.
Jill Billion: Iman will then provide an update on the status and the progress of our clinical programs, after which Eric will come and will present an update on our key financials and cash balance. He will also summarize the strategic priorities and the expected timelines for the year to come.
The year to come.
And all three of US will then be available to answer questions in the Q&A session.
Iman El-Hariri: Now, moving to slide four, for anyone new to the company, this is a brief overview of Aeritech focused.
No.
Moving to slide four for anyone new to the company. This is a brief overview of erotic focused.
Iman El-Hariri: everything is focused on the development of red blood cell-based cancer therapeutics, as you know. Our lead product, GRASPA, or AriasPAS, it's asparaginase loaded in.
Everything is focused on the development of Red blood cell based cancer Therapeutics as you know.
Our lead product grasp up areas for us.
<unk> loaded in Red blood cells.
Iman El-Hariri: It's targeting the cancer cells, altered asparagine and glutamine metabolism, it's a cancer.
Targeting the cancer cells, holter, disparaging and glutamine metabolism.
Iman El-Hariri: Graspa is currently in pre-regulatory phase in ALL.
Cancer metabolism agent.
The gross base currently in regulatory fees.
Iman El-Hariri: close to submitting our BLA, our file for approval.
Hello Silver.
To submitting our BLA filing for approval.
Iman El-Hariri: We have a phase one ongoing in first-line pancreatic cancer and a phase two in triple negative.
We have a phase one ongoing in first line pancreatic cancer and a phase III in triple negative breast cancer.
Speaker Change: We'll tell more. So we have also two manufacturing operations, two fully operational facilities, one in Lyon to serve the European.
We'll tell more so we have also.
Manufacturing operations to fully operational facilities, one in lieu to serve the European clinical trials and potential future market later in the second in Princeton, New Jersey for the U S.
Speaker Change: clinical trials and potential future market later, and the second in Princeton, New Jersey, for EOI.
Speaker Change: So we are very balanced in terms of shoulder base as.
And so we are very balanced in terms of shoulder base.
Speaker Change: Euronext and Nasdaq listed the company with roughly half 50-50 of the shareholders in Europe
Euronext and NASDAQ listed company with roughly 50.
50, 50 with <unk> in Europe .
In the U S.
Speaker Change: Now shifting to the highlights of the year, let's focus on the fourth quarter, on slide five.
Now shifting to the highlights of the year with focus on the on the fourth quarter on slide five and so 'twenty. One has really been in various special years on the one hand the euro.
Speaker Change: So 2021 has really been a very special year, on the one hand a year of tremendous execution, working
Tremendous execution working.
Speaker Change: the results of the TRIBECA-1 and the other clinical trials.
DNI towards as a result of the <unk>, one and the other in clinical trials.
Speaker Change: Tribeca-1 is our phase three trial in second-line pancreatic cancer.
Tribeca, one is always our phase II phase III trial in second line pancreatic cancer.
Speaker Change: And really in a race to get all our data out on time as we announced them.
Really you know in a race to get data out on time.
We announced them in October .
Speaker Change: Notwithstanding the severe impact of the COVID pandemic, they were reported as we had planned in October .
Notwithstanding the severe impact of the Covid pandemic they were.
Reported.
We had planned in October .
21 was also a year of great reception.
Speaker Change: when the trial did not meet its primary end point in.
When the trial did not meet its primary endpoint.
October last year.
Speaker Change: Now 21 was also a year of very good progress, in fact the year in which we moved.
Now 21 was also a year of very good progress.
Speaker Change: on the front of ALL from considering the potential to seek approval for GRASPA in ALL patients, in hypersensitive ALL patients.
During which we moved.
On the front of Elo, considering the potential to seek approval for <unk>.
Patients in hypersensitive PLL patients.
Speaker Change: to now being almost ready to file a BLA in this indication.
To now being almost ready to file the BLA in these indications.
Speaker Change: We've had, in 21, multiple interactions with the FDA, including a pre-VLA meeting.
In 'twenty, one multiple interactions with the FDA, including a pre BLA meeting.
We were granted fast track designation.
Speaker Change: FDA is still evaluating certain elements of our file, and we expect...
The FDA is still evaluating certain elements about file and we expect.
Speaker Change: We are almost ready with the dossier, so we expect we will be able to file quickly once the FDA has finished their evaluation of the outstanding.
We are almost already with the dose. So we expect we will be able to file quickly. Once the FDA has finished in depth evaluation of the outstanding.
Information requests.
Speaker Change: On the next topic, TRABECA1 indeed was a setback, but not all hope is gone for GRASPA, for areas passed in pancreatic cancer. In the TRABECA1 trial, we noted an interesting O.S. improvement.
Yeah.
On the next topic Tribeca, one indeed was a setback, but not all hope is gone for Russ huffer areas Paas in pancreatic cancer.
<unk> one trial, we noted an interesting with improvements.
Speaker Change: in a subgroup of patients, subgroup treated with fluropyrimidine and urinaltecan-based chemotherapy.
In the subgroup of patients.
Group treated with through permitting and get Ronald <unk> based chemotherapy.
Speaker Change: And this regimen represented approximately 40% of the patients in the.
The regimen.
This regimen represented approximately 40% of the patients in the <unk>.
In the trial.
Speaker Change: We have a phase one ongoing in, in fact, Georgetown. It's an investigator-sponsored trial at Georgetown University. There is a phase one ongoing, evaluating GRASPA in combination now, not with Fault Theory, but with Fault Theory.
We have a feast one ongoing in FIC Georgetown.
<unk> sponsored trial at Georgetown University, there is in a phase one ongoing evaluating <unk> in combination, though not with full theory, but will fulfill remarks and also it's also a fluor or permitting and <unk> based chemotherapy.
Speaker Change: And it's also a fluoro pyrimidine and urinaldehyde-based chemotherapy.
Speaker Change: What we've seen over the years is that indeed, the safety profile also looks good, and we see encouraging clinical activity in the trial.
What you've seen over the year is that indeed, the safety profile also looks looks good and we see encouraging clinical activity in the trial.
Demand will explain more.
Speaker Change: And then the last item here on the highlights, clearly, we announced it after the phase three results, strategic evaluation and search for partnering options. We are now evaluating valuable options.
And then the last item here on the highlights clearly we announced it.
After the phase III results strategic evaluation and search for partnering options we have.
No evaluating soluble options.
Speaker Change: stage. Not more we can say at this stage, but we hope to be back with more news in a month or
At this stage.
No we can see at this stage, but we hope to be back with more news in a moment or two from now.
Speaker Change: So here I'll hand over to Iman to provide additional detail on our clinical programs and expected timelines, and thereafter, as mentioned, to Eric for the financials and the key milestones. Iman, the floor is yours. OK, thank you, Gilles. Good morning, good afternoon.
So here.
And over two months to provide additional detail on our clinical programs and expected timelines and thereafter as mentioned to Eric for the financials and the key milestones.
The floor is yours. Thank.
Thank you James Good morning, good afternoon.
I hope not.
Alright.
Starting with slide number two.
Thank you just a quick reminder.
Did you think.
Iman El-Hariri: We reported back in October last year.
Since that time.
Back in October last year.
Iman El-Hariri: we reported that the study did not meet the primary influence, which was an overall survival, comparing eryaspase.
We.
We don't put it at this time.
Thank you.
Sure.
Okay.
Yes.
Keith.
Chemotherapy.
Thank you guys.
Iman El-Hariri: However, what we also have said last year is that there was a numerical difference on all efficacy indicators, including...
Hello.
Please go ahead.
Scott.
Yes.
Yes.
Indicators.
Of course.
My CFO .
Did he had controller.
Iman El-Hariri: interesting trend in one of the treatment groups where area fat is combined with irene
Sure.
James.
And one of the treatment.
Yes.
Brian .
Okay.
Iman El-Hariri: We continue to interrogate and dissect the data to get a better insight on the outcome of the study.
Thank you.
We continue to target.
So again steady.
Steady.
Just to get a better insight on the outcome of the study.
Iman El-Hariri: course beyond the obvious reason as we reported last year in terms of very well balanced treatment groups and subgroups.
Beyond the obvious CFO .
As we reported last year.
Got it.
Treatment groups.
Subsequent to <unk>.
Iman El-Hariri: There isn't really much we have seen to make us more intelligent on the outcome of the trial. And we actually had that study presented by Pascal Amel at ASCOGI at the beginning of this year. It was well received and there was some interest.
Et cetera.
When you get into any much we have to make us more.
Contingent on the outcome.
Yes.
And we actually had that study presented by basket.
Okay.
At the beginning of this year.
<unk> sorry.
Thank you.
<unk>.
Particularly from that discussions during the meeting.
Iman El-Hariri: We also continue to look at our search for the reasons we have had an advisory board again in January .
We also continue to.
Typically our session for today. So we have had an advisory board again in January .
Iman El-Hariri: And for two reasons, to see whether there is obvious reasons that we are not aware of, or secondly, is there any
And if we do any of this atg whether it is.
Obviously.
Yeah.
Secondly is there any.
Any pause for.
Iman El-Hariri: And again, with a group of the key opinion leaders, the interns continue to be there.
Sure.
And again.
The key opinion leaders.
The index continued to be ahead.
Iman El-Hariri: And there are some interesting ideas how to take this further.
Ken.
There are some interesting ideas how to take these Florida.
Entity.
Kitchen.
Iman El-Hariri: So moving to slide number 8, I'll switch gears now to ANL, and specifically in the indication in patients who developed hypersensitive reactions to other...
So moving to slide number eight on switching gears now to.
And he specifically.
The indications.
Patients, who would you get a pipe into that you had access to.
She needs for mutations.
Iman El-Hariri: And so, as you, again, remember, we have had.
<unk>.
As you again remember.
Iman El-Hariri: a meeting with, previously a meeting with the ADA last year and basically to
Amid increased.
PBT meeting with the agency last year in physically to discuss potential for.
Iman El-Hariri: potential for a path forward, taking an indication.
Iman El-Hariri: based on a lawful study, which is an investigator-initiated trial, and looked at.
Seeking an indication based on that.
Thank you Richie.
Thank you to initiate the trial and look to add to it.
Iman El-Hariri: of GRASPA in these patients who received OncoSpar and developed hypersensitive action and or silent inactivation.
Good afternoon.
In these patients.
Okay.
<unk> did you actually or site under our silent in activation.
Good bye.
Iman El-Hariri: 2020 during ASH meeting and showed that not only GASPA demonstrated sustained and improved asparaginase activity in this patient population.
To ensure getting ash meeting and ensure it does not.
On the gas there.
<unk> Street.
Thank you.
Nice activity in these patients total.
Total 55 patient, but also with treatment.
Iman El-Hariri: but also treatment was very well tolerated.
200 <unk> debt.
And so moving.
Iman El-Hariri: Slide number nine and again, I just touched base. We are as you mentioned we are almost ready to submit our Applications to the 88 we have had
Sure.
Slide number nine I think you just touched on.
Jim mentioned.
'twenty two.
Okay.
And applications.
To the east we have had.
Cornerstone.
It's actually the agency.
Iman El-Hariri: They have followed the pre-billing meeting. There were a lot of requests on all accounts, on the clinical, the non-clinical, and the TNC.
They have fallen on PBT.
<unk>.
Please.
On the Canadian consumer genetics.
Yes.
Iman El-Hariri: those requests and we're waiting for the remaining feedback.
With the agency to Anthony.
Thanks Glenn.
<unk>.
At that meeting feedback.
Iman El-Hariri: if we get the acceptance to file then hopefully we will be ready to file.
Hopefully if we get acceptance.
Finally in hospital would be an easy to find.
Imminently.
Iman El-Hariri: Of course, we will not just submit here in the United States, but we also subsequently would like to look for a path forward in Europe .
Of course.
Not just.
Yeah.
The mix.
Steve.
Still as a sequence you would like to note for the hospital.
Sure.
Iman El-Hariri: So moving to slide number 11, switching gears back to pancreatic cancer. And here, this is the investigator initiated trial led by Dr. Michael Snow in Georgetown University.
So moving to slide number 11.
And then switching gears back to pancreatic cancer.
Yeah. This is John .
Bye.
Michael.
Styling universities.
Iman El-Hariri: to assist the safety and durability of grass bar in combination with modified foot pruners, which is now
And this is such as you can.
To access the <unk>.
Thank you Scott.
In combination with your fiber footprint.
Very much the centre scanning first line. Thank you Kathy.
Iman El-Hariri: The study actually already reported that the first two doses is identified and it is 100 units.
The study actually.
Jean <unk>.
Is that the phase two dose.
I think 500 Julien.
Iman El-Hariri: kilogram, which is the same dose that we have used also in in Sri Lanka.
<unk>, which is the same dose that we have.
So.
And to be Cowen and <unk> analyst.
Ryan.
Iman El-Hariri: Again, some encouraging signal of activities, and that was presented also during ASCO G.I.
Yeah.
Again, some encouraging.
It signals of activity and that was presented to Jake Axel.
Iman El-Hariri: The full results will be expected towards the second half.
Yes.
Step four is done would be expected.
Towards the second half.
Yes.
Iman El-Hariri: And one more time, switching gears to this time to tripping negative.
One more time switching gears to the stomach to triple negative breast cancer.
Iman El-Hariri: As you know, we have had a proof-of-concept trial, FISTO study, combining RASPA with gem-carboplatin in a randomized setting with a small trial.
We have had a proof of concept.
<unk>.
Binding.
Jim Carboplatin.
Hi, <unk>.
Once the line 65 patients in total.
Iman El-Hariri: total, and that was in patients who received at least one prior therapy.
And that's one.
Efficient toward achieved at least the one at <unk>.
<unk> advanced Nash it does that you're expecting.
Iman El-Hariri: The study actually, following the outcomes, Rebecca won.
The study actually fully.
Iman El-Hariri: we opted to stop further enrollment.
The outcome typical one.
We opted to.
Iman El-Hariri: However, we continue to follow up the patients who are already enrolled in the trial, and we do expect to provide results on those patients again.
Toward that enrollment of patients in the study. However, we continue to object patients, who already enrolled and up time and we do expect to provide.
When those patients again by the third quarter.
Yes.
And to invest.
Iman El-Hariri: now and hand over to Eric Swaye, our Chief Financial and Chief Operating Officer for the update.
I CTO.
I'll turn it over to our.
Our chief financial Chief operating Officer.
That is.
Eric Soyer: Thank you. Thank you. Amen. Good morning, everyone.
Okay. Thank you thank.
Thank you Amy good morning, everyone.
Eric Soyer: As you see, I will focus this financial update for the first quarter of 2021 mainly on cash.
I will focus this financial update for the fourth quarter of 'twenty, one mainly on cash.
And we are on slide 13 of the presentation.
Eric Soyer: As of December 31, 2021, Eritrex had cash and cash equivalents totaling 33.7 million euros. And that's approximately 38.1 million dollars. And that's compared with 44.4 million euros as of December 31 last year, 2020.
As of December 31, 2021, I would take our cash and cash equivalents totaling $33 7 million Euro and thats, approximately $58 $1 million and that's compared with $44.
4 million Euro as of December 31 through 20 countries in 2020, which means that we've managed to limit the net cash utilization in 2021% to $10 7 million euros.
Eric Soyer: which means that we've managed to limit the net cash utilization in 2021 to 10.7 million euros.
Eric Soyer: The net cash utilization in operating activities and investing activities was.
The net cash utilization and operating activities investing activities was $57 1 million euro while in the same time financing activities in 2021 generated $44 7 million in Europe .
Eric Soyer: 57.1 million euro while in the same time financing activities in 2021 generated 44.7 million euro that included 34.6 million in combined net proceeds from the at the market ATM equity financing program that was 8 million dollars in February
That included $34 6 million in combined net proceeds from the at the market ATM equity financing program that was $8 million in February two.
Eric Soyer: Two registered direct offerings, one in April , $30 million, and one in December , $7.85 million, and a total of $11.4 million from the drawdown of four tranches of all convertible notes.
But just the direct offerings one in April 30 million and one in December seven 8 million.
Total of $11 4 million from the drawdown of four tranches of our convertible notes.
Eric Soyer: while in the same time the variation of the US dollar against the euro led to a 1.7 million euro positive currency exchange index.
While in the same time the variation of the U S dollar against the Euro led to a $1 7 million euro positive currency impact.
Eric Soyer: With that, we believe that Eritech's current cash position can fund planned operating expenses and current programs well into the third quarter of 2022.
With that we believe that <unk> current cash position confront planned operating expenses and current programs well into the first quarter of 2022.
Eric Soyer: And that is, of course, without considering the potential future proceeds from potential strategic and partnering options, which are ongoing as explained by the
And that is of course without considering the potential future proceeds from potential strategic and bottleneck options, which are ongoing as explained by <unk>.
Eric Soyer: Given these discussions, our event stage, the company will likely need for market regulation to present Proforma 2021 accounts to reflect the impact of a potential transaction on its operations. And consequently, and given the time needed to prepare audits and review Proforma accounts with market regulator, we are postponing the reporting of our full year 2021 financial results to a later date, and that will be in April .
Given these discussions orphan stage the company will likely need for market regulation to present pro forma 2021 accounts to reflect the impact of a potential transaction on its operations and consequently, and given the time needed to prepare audits and review pro forma accounts with market regulator will pose.
Funding the reporting of a full year of 2021 financial results to a later date and that's currently in April .
Eric Soyer: Now, and before we move to Q&A, a quick summary of our key strategic priorities for the coming month and upcoming key items.
Now before we move to Q&A, a quick summary of our key strategic priorities for the coming months and upcoming key milestones.
Items and this is slide 14 of the presentation.
Eric Soyer: As explained by Agile and Iman, the submission of our BLE dossier for area space in hypersensitive ELL has been a key operational priority in the recent months and still is. The dossier is now close to be ready and we look forward to being able to submit once the FDA has completed its review of the remaining information requests and gives us the green line to file the application. And we believe that should be in the second quarter.
As explained by reviewing them on the submission will be CFO asp's and oversensitive, that's been a key operational priority in the recent months and still lead the dose you know close to be ready and we look forward to be able to submit once the FDA has completed its review of the remaining information request and gives us the green light to fight the.
And we believe that should be in the second quarter of this year.
Eric Soyer: We also have two ongoing trials and our teams and the trial investigators are working on presenting data later this year.
We also have two ongoing trials and our teams in the trial investigators are working on presenting data later this year.
Eric Soyer: That's the phase two trial of area space in TNBC, triple negative breast cancer. The trial's name is Tribeca-2. And we expect to report data from the first patient in the third quarter of this year.
That's the phase two trial of <unk> in <unk> Triple negative breast cancer. The <unk> name is <unk> and we expect to report data from the first patient in the third quarter of future.
Eric Soyer: and the phase one ISD in first-line pancreatic cancer, the trial's name is RESPECT, with results expected in the second half.
And the phase one Isps in first line pancreatic cancer the phrase Namias respect with results expected in the second half of this year.
Eric Soyer: And of course, and last but not least, the ongoing strategic review and partnering process for which we target an update in the first...
And of course.
But not least the ongoing strategic review and bottling process for which we don't get an update in the first half of this year.
Eric Soyer: With that, I would like to thank you already for your attention. I will now open the call for any questions you may have. Like always, questions from the French speakers are welcome, although I've not had much success in the past. Chers tous, nous allons maintenant ouvrir la session de questions-réponses. N'hésitez pas à poser vos questions en français si vous le souhaitez.
With that I would like to thank you everybody for your attention and we'll now open the call for any questions. You may have like always questions from the French figures all welcome although have not had much success in the past just listen gentlemen, nobody else is shown to the customer of impulse visits it bump up with them.
Okay.
Eric Soyer: That's over to you. Thank you. If you have a question at this time, please press star then one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Again, to ask a question at this time, please press star then one.
Steve.
Ah preserve shelf that's over to you.
Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Again to ask a question at this time. Please press Star then one.
Speaker Change: And our first question comes from the line of Boris Peeker with Cowan. Your line is open. Please go ahead.
And our first question comes from the line of Boris <unk> with Cowen. Your line is open. Please go ahead.
Boris Peeker: Good morning or afternoon, I guess, I think that's my question. I just want to understand for Grasper and ALL, what is your commercial strategy? Can you talk about how much you plan to invest in commercialization and how do you see commercialization playing out?
Good morning, or afternoon I guess.
Thanks for taking my question I just wanted to understand.
<unk> what is your commercial strategy can you talk about how much you plan to invest in commercialization and how do you see commercialization playing out.
Speaker Change: Boris and it's actually morning. We're all three of us in Boston.
Hi, Boris.
Morning, where all three of us in Boston.
But so.
Speaker Change: One of the big reasons for the strategic partnering process that we announced after the Tribeca One setback is really that,
One of the big reasons for the strategic partnering process. The three that we announced after the Tribeca one setback is really good.
With a positive traffic of one clearly we would test.
Speaker Change: focus would have been on a go alone strategy in combination with with external vendors for back office, etc. But now clearly
The focus would have been on a go alone strategy in combination with external vendors.
Bankruptcies et cetera, but now clearly Hello Richard.
Speaker Change: but smaller indication, the focus for us is in the strategic partnering exercises, not only, but also commercial partnerships.
Significant smaller indications.
For Us we'll do it.
Strategic partnering exercise is indeed also notable leaf, but also commercial commercial partnership and so the most likely path forward will be that we have.
Commercial lives with a partner.
Speaker Change: Got it. So just to clarify, you have no plans to build a commercial organization on your own?
Got it so just to clarify you have no plans to build a commercial organization in Europe .
Speaker Change: We have a plan, we have a plan that is on our own, but with support of external vendors, specialized vendors.
We have a plan.
We have a plan that.
On a role but with support of external vendors specialized vendors. So.
But priority now at least.
Speaker Change: At least we're evaluating, I think we put it in the corporate deck, we're evaluating partnering options in parallel to further development of the Go Alone plan.
At least we're reevaluating I think we split it into corporate liquid evaluating partnering options.
Below two <unk>.
The development of <unk>.
To go alone plan.
Got it alright, thank you.
My question.
Speaker Change: Thank you. And our next question comes from the line of Lucy Codrington with Jeffries. Your line is open. Please go ahead.
Thank you Bruce.
Thank you and our next question comes from the line of Lucy Codrington with Jefferies. Your line is open. Please go ahead.
Lucy Codrington: Hiya, thanks for taking my question, just the one please. Just in terms of the path forward in pancreatic cancer, how much of that is contingent on the outcome of the first line data in the second half and
Hi, Thanks for taking my question just one for Jay.
In terms of the path forward in pancreatic cancer, how much of that is contingent on the outcome.
Skyline.
And data in the second half.
Lucy Codrington: is there something, is there a kind of threshold that you're looking for?
And.
Is there something is there a kind of threshold that you're looking for.
Lucy Codrington: Obviously, looking at the data to date with the 50% response rate, is there a particular bar that you're looking to meet in that trial? Or is it too small? And so therefore, what do we need to see in that data to give you confidence in that indication? Thank you. Thank you, Lucy. I'll hand this question to you.
Of the stake in the data to date.
With that response rate is that will be taking a thought that you were looking to meet in that trial.
So and it is today.
What do we need to see in that data and to give you confidence in that indication. Thank you.
Okay. Thank you Lucio and this question three months okay. Thank.
Lucy Codrington: So, it's a couple of things. Number one, in the first line, I guess you can say that
Thank you for the question.
No.
Just a couple of things number one in the first line. Thank you.
The respective study.
Lucy Codrington: As you know, it's a dose escalation trial, it's a small number of patients, so while the signal looks interesting compared to perhaps to what you would expect with the first dose.
Hi, Jim.
Dose escalation to Ian just one number of patients so wildly.
The signal looks interesting compared to perhaps to what you would expect with.
Deferred for Salix alone.
I think we need to be closer to the closing two if I can just one number of patients but.
Lucy Codrington: But the most important point here is that really the consistency of the encouraging evidence, so not only from the respected trial, but also from to become one.
But the most important.
Scott.
The consistency of that.
The encouraging evidence so we're not only from that expected giant but also.
B Cowen and study.
Is that the combination with <unk>.
Adding interest Ken on fine teams to be really a logical next step and that was still at the sentiment.
Lucy Codrington: by almost unanimously by all our key opinion leaders.
Sure.
Unlocked unanimously by all our key opinion leaders so next steps.
Lucy Codrington: So next steps, really, and we looked at different options, whether.
Again, we looked at different options with our App to go into the finish line with the option of whether to go into a second.
Lucy Codrington: going to first line would be a good option whether to go into a second or third line.
Lucy Codrington: And we think maybe future studies should be a smaller trial.
The line on and we think it may be fewer Chinese that you should be at one time.
Lucy Codrington: It doesn't make much sense for us to repeat a large trial like Tribeca one.
Doesn't make much sense for us to build a larger trial activity go on foot indices.
Lucy Codrington: trial and therefore indications like for innocence, a third-line setting or indications for innocence
Wanted to try it and therefore indications like for instance, <unk> or indications for instance put performance status patients, which.
Lucy Codrington: which we actually don't see to be differentiated whether it is good performance or poor performance from all our trials. So these are some logical options that were basically flagged by our Q opinion leaders. And so to your point, if you go to any of these indications, of course, we will have.
Should we actually don't seem to be differentiated whether its just good performance or performance from from all our clients. So these are some logical options that were basically flagged by our COO.
Key opinion leaders and so to your point if you go to any of these indications of course, we would have to.
Lucy Codrington: Most probably will not be a survival study, but will be, to your point, a response trial or progression-free survival. Maybe a read one year or two years, or six months, sorry, or one year or so. So these are the options.
The project will not be a survival study, but it would be to your point.
As for.
Progression free survival, maybe Eddie one year after year.
Six months one year. So so these are the options I think once we settled on one of these options. The first thing we have to do is to go antiques Antefix advisors with anti <unk> with a surrogate endpoint would be potentially approval end point for that accelerated.
Lucy Codrington: I think once we settle on one of these.
Lucy Codrington: The first thing women have to do is to go and seek...
Lucy Codrington: with the NDA to see whether a surrogate endpoint would be potentially approval endpoint for an accelerated approval.
Lucy Codrington: certainly some work to be done. One of the things that we are currently doing, and I'm sorry for the lengthy response, is that we're looking, you know, some potential either, it may be preclinical, and looking also at biomarkers to further understand the signals that we have seen in ulcerative colitis.
Outgrowth I still so there is certainly some work to be done.
One of the things that we are currently doing and I'm sorry for the links. The response is that we were looking.
Some potential.
Preclinical and look at what's in our Biomarkers.
To further understand the thickness that we have seen in.
Your line.
Does this answer your questions.
Speaker Change: Sure can I just confirm you said third line patients as one of the potential options? Okay great thank you.
So can I just confirm you said the Dod in patients as well as the potential auction okay. Great. Thank you.
Speaker Change: Thank you. And again, if you have a question at this time, please press star then one.
Thank you Ken if you have a question at this time. Please press Star then one.
Speaker Change: And I'm showing no further questions at this time, and I would like to turn the conference back over to Gil Behan for any further remarks.
And Im showing no further questions at this time and I would like to turn the conference back over to Gil Beyen for any further remarks.
Gil Behan: Thank you, Michelle. Thank you all. Thank you for your participation and attention and for your continued support.
Thank you Michelle. Thank you all thank you for your participation and attention.
And for your continued support of <unk>.
Gil Behan: always, we'll keep you posted on further development and we look forward to speaking soon.
As always we'll keep you posted on alternative developments and we look forward to speaking soon the next call.
Yes.
Okay.
Thank you all have a great day.
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: 🎵
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Okay.
Yes.
Yes.
Okay.
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