Q1 2022 Erytech Pharma SA Earnings Call
Okay.
Okay.
Good day, and thank you for standing by and welcome to Ametek's business update.
Good day and thank you for standing by. Welcome to Aerotech Business Update and Final Highlights for the first quarter of 2022.
For the first quarter of 2020 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 the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero.
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 the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Jill Byan, Chief Executive Officer. Ms. Byan, please go ahead.
I would now like to hand, the conference over to Joe Bryant, Chief Executive Officer, Mr. Brian . Please go ahead.
Thank you Norma. Good afternoon. Good morning. Bonjour à tous.
Thank you Norma.
Good afternoon, good morning <unk>.
Thank you for joining this conference call to discuss the key business highlights year to date and the financials for the first three months of this year.
Thank you for joining this conference call to discuss the key business highlights year to date and the financials for the first three months of this year. We announced our business and financial update yesterday evening and the press release, also the webcast presentation, can be found on the Investor Relations page of our website.
Our business and financial update yesterday evening and the press release for the webcast presentation can be found on the Investor Relations page of our website.
Joining me on the call today are Dr. <unk>, our Chief Medical Officer, and Erik <unk>, our chief financial and Chief operating Officer.
Joining me on the call today are Dr. Iman El Hariri, our Chief Medical Officer, and Eric Zwaje, our Chief Financial and Chief Operator.
Before starting on slide two I'd like to draw your attention to the disclaimer.
Before starting, on slide two, I'd like to draw your attention to the disclaimer, reminding you that today's call includes forward-looking statements such as relating to the company's operations, timelines, and financials. And as you know, they all involve risks and uncertainties that could damage actual timings and results to different materials.
Reminding you that today's call includes forward looking statements such as relating to the company's operations timelines and financials and as you know the legal risks and uncertainties that could damage actual timings and results.
Cause actual results to differ materially.
Okay.
Switching to slide three the agenda of the call.
Switching to slide three, the agenda of the call, I will, as usual, start with a short introduction, present the key business highlights of the year to date, focusing on the more recent ones.
We will as usual start with a short introduction presents to key business highlights highlights.
Year to date, focusing on the more recent ones the ones that occurred after our last call in March it's not that long ago.
that occurred after our last call in March, it's not that long ago, Iman will then provide an update on the status and the progress of our clinical programs, after which Eric will present an update on the key financials, cash balance, and he will also summarize the strategic priorities and expected milestones for the year to come. After that, all three of us will be affected.
Demand will then provide an update on the status and the progress of our clinical programs after which Erik will present, an update on the key financials cash balance and people also summarize the strategic priorities and expected milestones for the year to go.
After that ultra of us will be available for Q&A.
Moving on to slide four and this is really for anyone new to the company and for completeness brief overview.
Moving on to slide four, and this is really for anyone new to the company and for a complete brief overview.
You know, everything is focused on the development of red blood cell-based cancer therapeutics with the lead product CRASPA, CRASPA, or AREASPAs, which is asparagus loaded in red cells.
You know everything is focused on the development of Red blood cell based cancer therapeutics with elite Crespo Cross platform areas.
Which is asparaginase loaded in red cells targeting.
targeting the cancer cells altered asparagine and glutamine metabolism.
Targeting the cancer cells, ultra disparaging and glutamine metabolism.
With GRASPA we are now, and for some time now, in pre-regulatory phase in ALL, acute lymphoblastic leukemia. We're in the process of working towards the filing of our BLA in this indication.
With <unk>, we are now.
And for some time now.
Regulatory phase in <unk> acute lymphoblastic leukemia.
In the process of working towards the filing of our BLA in this indication.
In parallel, we have a phase one ongoing in first line pancreatic and a phase two in triple negative breast cancer, the amount will provide an update shortly.
In parallel we have a phase <unk> in first line pancreatic end of phase two in triple negative breast cancer demand will provide an update shortly.
Our product candidates are manufactured at two fully operational sites, one in Lyon for Europe and since very shortly I'll explain more, you will have seen the news a few weeks ago that we sold our Princeton facility, the second is now through a supply agreement with Catalan at our former manufacturing facility in Princeton, New Jersey for supply to the
Our product candidates are manufactured at two fully operational sites one in view for Europe and since very shortly I'll explain more you will have seen the news a few weeks ago that we sold our Princeton facility. The second is now through a supply agreement with Catlin at our former manufacturing facility.
Princeton New Jersey.
For supply to the U S North America I should say.
So and that is indeed the highlight of.
So, and that's all indeed the highlight of the quarter, or the year to date, slide five. You saw the, probably the announcement was on April 25, the sale of our Princeton facility to Catalan.
Two quarter toward the year to date to slide five.
You saw the <unk> announcement was on April 25, the sale of our Princeton facility to Catlin.
sold aside for a consideration of 44 and a half million.
We sold the site for a consideration of $44 5 million.
In the meantime, already our entire team, 40 people in total, transferred to Catalan's and are working at the site for Catalan's and also for us because we entered in a long-term supply agreement with Catalan's for the manufacturing and the supply of our lead product.
In the meantime, already our entire team 40 people in total transferred to Catlin and are working at the site for Catlin.
And also for us because we entered into a long term supply agreement with <unk> for the manufacturing and the supply of our lead product.
So on the one hand, it was with pain in the heart to see our beautiful site and our great team go to Catalans. But overall, we were very pleased to have been able to secure this deal, long-term supply agreement with one of the leading CDMOs in the field.
So on one hand, it was with pain and hard to see our beautiful site and our great team go to Catlin.
But overall, we were very pleased to have been able to secured.
This deal long term supply agreement with one of the leading CDN most in the field.
And obviously significantly reducing the cash burn of the facility the facility was.
And obviously, significantly reducing the cash burn of the facility, the facility was way too big for us now after the setback in the pancreatic cancer. So, I think we found a very good solution here to secure supply all in reducing the cash burn and some new cash, obviously, entering the company.
Too big for US know after the setback in the pancreatic cancer. So I think we found a very good solution here to secure supply.
In reducing the cash burn and so new cash obviously entering the company.
And I want to take the occasion to thank our team for great efforts and contributions to everyday.
And I want to take the occasion to thank our team for great efforts and contributions to Airtake. They made this site a real landmark site and that is also what Catalan saw and obviously we wish them all the best for their new future in their new context and clearly will remain in close contact as they will continue to produce our grasp of product for our ongoing trials and hopefully also for the commercial supply in the not too far away future.
They've made this site.
<unk> site and digital so what catlin.
Obviously, we wish them all the best for their new future.
In their new context.
We will remain in close contact.
As they will continue to produce our <unk> product for our ongoing trials and hopefully also for the commercial supply in the not too far away future.
The sale of the facility has increased our cash position to approximately 55 million Euro, approximately 60 million dollars, although the dollar is changing rapidly these days, which Eric explained more, but indeed it has.
The sale of the facility has increased our cash position to approximately 55 million euro approximately $60 million. Although the dollar is changing rapidly these days.
Which.
So Eric explained more but indeed it has.
combination with the reduction of the cost basis extended our cash horizon.
In combination with the reduction of the cost basis extended our cash horizon.
until approximately mid-2024, so a bit more than two years.
Until approximately mid 2024, so a bit more than two years.
And then the next question of the slide five, the question is clearly, what will we do with this money? And the answer is relatively simply. We will continue to focus on the three priorities we are working on. And the first one, obviously, is our attempt to get the BLA submitted for BRASPA to get the approval for BRASPA in hypersensitive ALL patients in the US first. Imam.
And then the next question will see in slide five the question is clearly what we do with this money.
And the answer is relatively simply we will continue to focus on the key priorities. We are working on and the first one obviously is.
Sure.
Attempt to get the BLA submitted for <unk> to get the approval for <unk> in hypersensitive ALLL patients in the U S first.
We will provide an update.
The second is to continue what we've been doing, develop innovative medicines for difficult to treat diseases and this leveraging our red blood cell encapsulation program or technology.
The second is to continue what we've been doing develop innovative medicines for difficult to treat diseases.
Leveraging our red blood cell encapsulation program.
Our technology.
We have, as I mentioned already, two clinical programs ongoing.
We have as I mentioned already two clinical programs ongoing.
both of them expect to have results in the second half of this year, and we continue to work on a number of
Both of them expect to have results in the second half of this year.
As we continue to work on a number of preclinical opportunities preclinical opportunities.
preclinical opportunities, because our ERICAPS technology is very versatile. Many types of molecules can be encapsulated, many ways to use the red cells. And a new program that we're increasingly enthusiastic about, and we recently presented results at the conference on the Red Blood Cell Society, it was in Italy, is to use the encapsulated red cells to develop extracellular physicals, exosome-like.
Our <unk> technology is very versatile many types of molecules can be encapsulated in many ways to use the red cells.
Our new a new program that we are increasingly enthusiastic about and we recently presented results at the conference on the Red Blood cell Society. It was in Italy is to use.
The encapsulated threat cells to develop extra cellular physicals at <unk>.
We have seen some very interesting first results, ex vivo results. We're continuing to work there, and we hope that this indeed will build a next pillar to the pipeline of ARIES.
We have seen some very interesting first results ex vivo results, we're continuing to work.
That is indeed a niche.
Pillar two the pipeline of every day.
And then the third priority is to continue to search for strategic options for everything to complete the story the Catlin deal.
And then the third priority is to continue the search for strategic options for aerotech to complete the story, the Catalan deal, and you followed it after the phase three results in pancreatic cancer.
Followed it after the phase III results in pancreatic cancer.
Retailers, especially as the advisor to <unk> to help us looking for.
retained a specialized advisor, Torea, to help us in looking for the strategic options for the company. The Kaplan deal was the first step, I would say. We are now continuing to look at a series of valuable options. They range from looking for a commercial partner for Graspa.
Strategic options for the company Catlin deal was the first step I would say.
We are now continuing to look at a series of value valuable options.
<unk> from <unk>.
For commercial partner for Grubhub.
Extending the pipeline.
by leveraging our development and manufacturing capability to potentially broader strategic options.
By leveraging our development and manufacturing capability to potentially broader strategic options.
Not much more we can say at this stage, obviously, but stay tuned. We'll keep you posted on our progress.
Not much more we can say at this stage, obviously, but stay tuned we'll keep you posted on our on our progress.
And I will stop here and hand over to Imam who will provide additional details on our clinical programs and their milestones.
And I will stop here and hand over to Eamonn.
Who will provide additional details on our clinical programs and their milestones.
after which Eric will come to present the financials and the further milestones of the year.
After which Erik will come.
The financials and the further.
Milestones of the year.
So.
The floor is yours.
Thank you.
Thank you, Jim, good morning, good afternoon. Bonjour à tous. So I have few slides to give regarding the clinical update. So I'll start with slide number eight. And here the focus is on the key project, the acute lymphoblastic leukemia. And so here I'm going to provide a quick update in terms of our progress towards the filing for approval in the high-persensitive patients.
Good morning. Good afternoon. Please we would actually so I have two.
I'd like to give regarding the clinical update.
Barclays.
Slide number eight.
Just a quick question.
On the key projects.
The kitchen from Lucky to Kenya.
Yes, im going to provide a quick.
In terms of our progress towards the filing for approval.
And my question.
Susan.
So, as you know, we have a study which was in the theater industry that signed an awful study, which was reported back in Turing Ash 2020, where area spas or grass spa was given in patients who have developed hypersensitivity reactions to prior asparaginase therapy. And in that study, there was a sustained prolongation of asparaginase activity, and patients were able to receive the intended courses of treatment.
So as you know.
We have and starting with <unk>.
Katherine you can just sign Dunhill for study.
As we reported back in.
<unk> 2020.
It is part of Grasberg with given ambitious will have developed have pricing actions.
Thank you Ms therapy and in that study there was a sustained prolongation of I suppose your needs of Davidson.
<unk> with Citigroup.
The courses of treatment and was that suite.
And with that, we actually made the decision to move forward in seeking an approval for this indication in patients with hypersensitive
We made the decision to move forward and seeking and and.
Approval for this indication in patients with high prices.
And J D.
It's important to note that there is already an approved product and you're not just safety or needs, which was approved.
It's important to know that there is already an approved product in the United States which was approved mid of last year.
Over the last year.
So moving to next slide, number nine and where we are today on the BLA front will continue to have the discussion and the dialogue with the with the agency and really can submit 2020 you may recall that we have also our pre delay meeting last June .
Moving to next slide number nine.
Where we are today on the BMA front, we'll continue to have the.
The discussion and the dialogue with that with Asia and.
Thank you.
You may recall that we have also I'll, let <unk> Inc.
And lastly, Sean.
and where we received was very collegial meeting and we had a very constructive feedback on our plan and the structure for the PLA to
And we will do.
Steve.
Very collegial meeting.
Are.
Are there any constructive feedback on our plan on this chart for the P&L.
I'm just wondering Anthony meeting, we were granted fast track designation.
Following that pre-bill meeting, we were granted first-track designation, which we continue to increasingly like because it enables our continuous interaction and dialogue with the agency.
We continue to increase.
Yes.
Because it enables our continuous interaction and dialogue with the agency.
When we are today, we have.
Where we are today, we have an ongoing discussion with the agency. They are continued to review information as they request on an ongoing basis.
Ongoing.
Question with the agency the odd continue to give you information as data quick ongoing basis.
And recently, we are particularly part of the submission, as you may know.
Recently, we.
And particularly you part of the submission.
Al.
or similar in Europe is we have to have a pediatric plan or pediatric waiver. And so this pediatric plan is currently in the view. We have received the initial feedback from the agency.
Which is also similar in Europe is we have to have at the Jetblue will be Joseph <unk>.
And so this project is currently in review we have received initial feedback from the agency.
And so we will be providing our revised application for the pediatric.
We will be providing our revised.
Applications for the project.
to be reviewed by the PTA committee and the FDA firm.
If you'd like to protect the committee of the FTE front.
With that, once we have a green light from the agency, we will move towards our daily submission.
Doug.
Yes.
Once we have the green light from the agency, we will look to.
Our BLA submission.
We'd like to take more of a staggered approach, so we file first in the United States and then we go back to Europe and start looking for the potential for also filing and seeking similar indications.
We'd like to take more of a staggered approach.
We filed first and Youre not just going.
It goes back to you on this does taking for the potential filing of Jacobs similar indications.
So moving to slide number 10, I'll switch gears to other clinical programs and I will start with Trivica one.
So moving to slide number 10, so I'll switch gears to other clinical programs and our new stock with QB Cohen.
As you know, with our physical trial in second line pancreatic cancer, we have presented the key highlights from the study a few months ago at ASCO GI.
As you know I'll, let this does John in second line. Thank you at this time, Sir we have presented the key highlights from this thank you.
Do you want to ask with Gi.
And in that study, we have also seen an interesting signal in a subgroup of patients based on a pre-planned analysis. So we will continue to assess the data and work with our QOLs to see what merits further investigation in that disease.
And in that study, we have with Sue Keenan.
And an interesting signal in a subgroup of.
This is based on a pre planned analysis.
We continue to assess the data and work with our Julian J C.
Matt it's fairly large.
<unk>.
In that disease.
The respective trial, which is the MVC Gator initiated trial led by Georgetown, will continue to enable patients and we are really on target to expect results from the center around the second half of this year.
That is Victor Zion.
And just to get to initiate the trusted advisor stolen.
Yes.
Two enrolled patients and we are on target to expect results.
Following from the center around the second half of this year.
Lucky, but lucky.
Last but not least, the update on TRPECA2, as you know, this was our proof-of-concept trial in triple negative breast cancer, where GRASPA was combined with gemcitabine and carboplatin in metastatic disease.
<unk> as you know this was our total tie in.
In <unk> negative breast cancer, where grasp of voice.
Combined with James that could be an uncomfortable flattish in metastatic disease.
So, given that Rubicon results, we completed this study and so we completed the enrollment at least for almost close to what we would have expected for an interim analysis, so it's close to 30 patients in total. And again, we are expecting the results during the Q3 of this year. We are currently doing a lot of data cleaning to be able to report the results.
Given that should be calling results from.
Keith at this <unk> also we completed the enrollment can you just for one was close to what we would have expected for an interim analysis with close to 30 patients in total and again, we are expecting the results.
Getting that Q3 of this year.
Currently doing a lot of data keybanc.
To be able to report the results of those titles.
So I think with this I will stop here and then hand over to Eric for the remaining of the financial update and the strategic priorities. So Eric, it's over to you.
With this I will.
I'll stop here, and then hand over to Eric for demanding with a financial update on the strategic priorities.
Eric over to you.
Thanks, a lot Matt and thank you good morning, everyone.
We're now reviewing the financial highlights for the first quarter of this year. We're on slide number 12 of the slide deck. And we are starting with PMC.
We are now reviewing the financial highlights for the first quarter of this year.
Number 12 of the slide deck.
And we are starting with P&L inflammation.
You can see that net loss for the first quarter of 2022 was $11 9 million Euro.
Table.
<unk> with a 001 7 million improvements it was minus five 5% in operating loss.
Is there a point 7 million decline in net financial income.
Theoretically 7 million improvement in operating loss was attributable to the $2 4 million decrease in preclinical and clinical development expenses.
The 0.7 million improvement in operating loss was attributable to the 2.4 million decrease in pre-clinical and clinical development expenses.
And that was upset in part by the 0.9 million decrease in other income from R&D tax credit.
And that was offset in part by the 0.9 million decrease in other income from R&D tax credits.
but both reflecting the decrease in the company's clinical development activities.
But both reflecting the decrease in the company's clinical development activities.
In the same time, GNA expenses increased by 0.8 million euro and that was mostly related to legal and due diligence expenses for partnering activities.
In the same time G&A expenses increased by 0.8 million Euro and that was mostly related to legal and due diligence expenses for partnering activity.
We're now moving to the next slide, slide number 13 for comments on cash.
We're now moving.
To the next slides starting with a 13 four comments on cash.
As of March 31st this year, ARITEC had cash and cash equivalence totaling 25.1 million euro and that was approximately 27.9 million US dollars.
As of March 31, this year.
Cash and cash equivalents totaling $25 1 million Euro and that was approximately $27 9 million U S dollars.
compared with €33.7 million as of December that year.
Paired with $33 7 million Euro as of December last year.
The $8 6 million decrease in cash position during the first three months of feature with the results of $10 7 million net cash utilization in operating and investing activities.
The $8.6 million decrease in cash position during the first three months of this year was the result of a $10.7 million net cash utilization in operating and investing activities.
and a 1.8 million euro generated in financing activities, and that included a 2.3 million
One 8 million euro generated in financing activities and that included a $2 3 million.
Euro, prepayment of a portion of the expected 2021 R&D texture.
Prepayments are a portion of the expected 2021 R&D tax credits.
And the same time the variation with U S dollar against the Euro led to a <unk> 3 million Euro positive currency exchange impacts.
In the same time, the variation of US dollars against the euro led to a 0.3 million euro positive currency exchange impact.
Please note that the company in that period but also since a long ago has not drawn any new chance on the convertible node facility actually since August 21. And as of September 21, there were no outstanding and unconverted nodes.
Please note that the company.
And thats for us but also.
Since a long ago is not drawn any new tranche of the convertible notes facility actually since August 21, and as of September 21, There were no outstanding Unconverted unconverted notes.
And the company does not plan to drill any further.
and the company does not plan to draw any further OCAPSA convertible note tranche until the expiration of the financing facility next month.
<unk> convertible notes tranche until the expiration of the financing facility next month.
As already mentioned by Gilles, the sale of the Princeton facility for 44.5 million US dollars, approximately 40 to 41 million euro, depending on the exchange rate, has brought Eritrex cash and cash equivalents to approximately 55 million euro, which is about 60 million US dollars at closing of the transaction on April 22.
As already mentioned by Gilles the sale of the Princeton facility for $44 5 million U S dollars approximately 40 to 41 million euro depending on the exchange rate as brought everything is cash and cash equivalents to approximately 55 million Euro which is about $60 million at closing of the transaction.
'twenty two.
With that, and further to general cost reduction efforts, which are already undertaken, and the reduction in yearly cash disbursements of approximately $7.5 million USD really take to running costs of the Prince and Facility
And further to general cost reduction efforts, which are already undertaken.
And the reduction in yearly cash disbursements of approximately $7 5 million U S dollars really seek to running costs of the Princeton facility.
We believe that the company's current cash position can fund its current development programs and plan operating expenses to meet 2024.
We believe that the company's current cash position can fund its current development programs and planned operating expenses to meet 2020.
Now, and before we move to Q&A, we're now on slide number 14 of the presentation, for a quick summary of our key strategic priorities and upcoming related chemisomes over the next 12 months.
Now and before we move to Q&A.
Now on slide number 14 of the presentation for a quick summary of our key strategic priorities in the coming related key milestones over the next 12 months.
Already stated by Gérald Himan, the submission of OBLA dossier for aerospace in hypersensitive ALL is still a key operational priority for the coming weeks and months. As explained, 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 light to file the application. We currently target submission by the end of the third quarter of this year.
Already stated demand the submission of our BLA dossier for aerospace in hypersensitive.
Is still the key operational priorities for the coming weeks and months as explained.
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 light to file the application. We currently target submission by the end of the third quarter of this year.
We also have two ongoing trials and our teams in the trial investigators are working on presenting data to date.
We also have two ongoing trials and our teams and trial investigators are working on presenting data to date.
Starting with the phase II trial of aerospace in <unk>. The trials name is trying to get to where we expect to report data in the third quarter of this year.
starting with a phase two trial of area space in TMBC. The trial's name is Trivica II, where we expect to report data in the third quarter of this year.
and the Phase 1 IST trial in the first line pancreatic cancer. The trial's name is RESPECT.
And the phase one <unk>.
Trials in first line pancreatic cancer trials name is respect.
with results also expected in the third quarter of this year.
With results also expected in the third quarter of this year.
And of course last but not least the ongoing strategic review and partnering process.
And of course, last but not least, the ongoing strategic review and partnering process.
The sale of the Princeton facility to Catalan was already a first step in that process, and that gives us the means now to pursue the GRASPA VLA, complete the ongoing trials, and pursue the most attractive preclinical programs.
Sale of the Princeton facility to Covenant was already a first industrial assessed and that gives us the means now to pursue the <unk> BLA complete the ongoing trials and pursue the most attractive preclinical programs.
And when they are looking at options for the further development and commercialization of our real estate and for ways to leverage our clinical development and manufacturing capabilities, including broader strategic options.
And we're now looking at options for the further development and commercialization of area space and for ways to leverage all clinical development and manufacturing capabilities, including broader strategic options.
With that I would like to thank you already for your attention and we'll now open the call for any questions. You may have for freighter noma over to you. Thank.
With that, I would like to thank you already for your attention and we'll now open the call for any questions you may have. Pufferator, Norma, over to you. Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.
Our first question comes from Boris <unk> with Cowen. Your line is now open.
Our first question comes from Boerspeaker with Cowan. Your line is now open. Good morning. Thanks for taking my question. I guess maybe let's start with ALL. Assuming you get approval, can you comment on the commercial potential in hypersensitive ALL?
Good morning, and thanks for taking my question.
I guess, maybe let's start with al.
Assuming you get approval can you comment on the commercial potential and hypersensitive parallel.
Hi, Boris I'll take this question. Thanks, Thanks, Rick So a hypersensitive PLL patients who develop in these hypersensitive to the U S. It's the Pegylate a disparate <unk>, which is the <unk> already as far as it.
Hi, Boris. I'll take this question. Thanks for it. So, hypersensitive ALL, it's the patients who develop hypersensitive in the U.S. It's the Pagylated Aspargenase, which is the Oncospar or the Asparless.
roughly numbers vary but around 20% of the patients will develop these hypersensitivities leading to about a thousand patients in the US every year.
It's roughly.
The numbers vary but around 20% of the patients who will develop these hypersensitivity leading to about a thousand patients in the U S. Every year with these forms of hypersensitivity or.
of hypersensitivity which includes sort of silent deactivation.
Which includes sort of silent in activation.
Got it and what do you think kind of a reasonable pricing is in those patients.
Price levels for relays are high, so relays is drug that needs 12 to 14 injections per month up to five files, each file in the order of $4,000, so you see price ranges from between
Price levels for Riley's are high so riley's drug that needs 12 to 14 injections per month up to 500 vials each vial in the order of $4000. So you'll see price ranges from between.
So.
a little bit below 100,000 and up to 200,000 per month.
Little bit below 100000 added up to two.
200000 per.
Per month.
So that's one of the more expensive oncology drugs.
So.
It's one of the more expensive oncology drugs.
And the advantage we with the areas pass is it's only it's set up every other day. In fact, there's a rail is now got Monday, Wednesday, Friday injections, so it's 12 times per month. But we can have two times per month. So it's every other week goes in with areas pass.
And the advantage we with our response has been totally instead of every every other day.
O'reilly Sunoco Monday, Wednesday, Friday injections. So it's.
12 times per month.
But we can have two times per month.
The other week dosing every other month.
Got it.
And my second question on Tribeca, too, what do you need to see in that study to continue with triple negative breast cancer?
My second question on Tribeca, too, what do you need to see.
In that study.
To continue with triple negative breast cancer.
Leave this question to Ivan.
And Boris, can you repeat the first part on the Q2? Yeah, I'm just talking about the Tribeca II, the triple negative breast cancer study that you guys are running. What do you need to show in this trial in order to justify further investment in the
What is can you repeat that.
The first Boston that Utah.
Can you just talk about the Tribeca to the triple negative breast cancer study that you guys are running what do you need to show.
In this trial in order to justify further investment in breast cancer.
Okay, sure. Because it was a proof-constrials, the primary endpoint is disease control rate. And then we have a key secondary endpoint, which is objective response as well as progression for the survival. So we would like to see really a difference. It's a comparative trial. So we'd like to see a difference. I think at least, if I remember, about 20%
Okay sure.
It was at risk pregnant.
Primary endpoint is disease control rate and then we have a key secondary objectives.
Objective response.
Progression free survival.
Like you see a difference it can product is from the line, we'd love to see additions I think Keith if I remember president with with 12% the difference.
which represents the difference from the control on to see that there is an interesting signal of activity to keep it further into larger trials.
One.
So D C that cities and servicing.
Davidson.
Thank you.
Marcia.
Got it thank you for taking my questions.
Yeah.
Thank you.
Our next question comes from Jacob <unk> with Cowen Your line is open.
Our next question comes from Jacob McHale, with Kevin, your line is open.
Hi there, and thanks for taking my question. I'm just curious if you can provide any additional color on the kind of discussions you're still having with the FDA on the BLA for ALL. What additional information have they asked of you?
Hi, there and thanks for taking my question.
I'm just curious if you can provide any color on the kind of discussions you're still having with FCA on the BLA for <unk>.
All information have they asked of you.
Thank you Jacob, I think Iman is the best place to answer these questions also.
Thank you Jacob.
The amount is best placed to answer these questions also.
Okay. Thank you. Thank you, Jacob. So, when we had actually the continuous discussions, they, you know, it's with, you know, on a clinical front as well as there are, in fact, in each module.
Okay. Thank you.
Hi.
Thank you Jacob.
When we.
Actually this is a continuous discussion.
And all of you and it comes from.
They're interacting with Jpmorgan.
For example, on the same field, there were lots of information that they requested, which they are still under review. And we get, like every few weeks, we get a response on this as an accepted proposal, et cetera.
For example on that thank you.
Inflammation that data question.
Thank you.
Under review and we get Lucky like every.
Every few weeks to get a response on that.
Accepted proposal.
It's Michelle.
And on the non-clinical, there was a request to have a rationale for a development or why we should not be doing a development and toxicity study or provide a rationale, we've been waiting for some of the feedback and so forth. So these are the things that...
On the non genomic Ken.
There was a request to have additional four.
Great.
You should not be doing at the gentlemen, and toxicity studies.
Beth will provide the data from that.
And we think from Zelman Duffy.
So for US these are the things Scott.
you know, when we provided our structure for the DSA, they subsequently asked some questions and information that they wanted to review prior to the actual BNA DSA, and that's exactly what is happening.
One when we provided our production for Davinci. The subsequently of some questions and information that they want to if you like.
Ashwin do you need this year and that's exactly what is happening.
I also alluded to the point that part of the submission is that you have to meet the requirements for pediatric plan or pediatric liver.
You alluded to the point that part of the submission is that you have to meet that requirement for pediatric plan or Jackie Goldberg.
And since this implication is also including pediatric patients, we are not seeking a pediatric waiver. So we provided information on how we would, you know, address the whole thing around the pediatric plan. And so these are, again, additional responses from the, questions from the agency, we are working on these.
This indication is also including Jesse confusion, we have not.
Looking at the Jesup, whereby we provided information on how we.
Yeah.
Today, the hosting of Andhra Pradesh.
And so these are again additional responses from the questions from the agency with what's going on this.
The next meeting for innocence for the pediatric committee is in July which they will review our revised application. So you can see it's a very effective process, more or less. We get questions, we respond, we may get additional questions or the issue or the topic is closed and moved to the next meeting.
And it sounds for Debbie Jetson Committee James Your line.
Which would be when did your audio device applications. So you can see it does vary and that of course is more or less.
Good question would respond we may get additional questions or Dan.
And the issue or the topic is closed move to the next step.
Which is actually by the way that it has equal hockey when we reach the <unk> fees, we know what.
which is actually, by the way, very helpful because hopefully when we reach the BLA fees, we know what the agency is requiring further PCA, and so that iterative process is also helping us to continue improving our overall decisions of how to address these specific topics.
The agency is requiring further equity and I'm sure that answered. Your question is also helping us to continue improving our overall.
In terms of how to address specific topics.
Okay I see thank you I also have another question.
I see, thank you. I also have another question, so besides the larger indications that require a lot of money to pursue, are there any smaller ones or POC indications that you could consider investigating with area space?
And besides that.
Besides the larger indications that require a lot of money to pursue are there any smaller one case.
That you could consider investigating what area.
I will take that question. Yeah, sure. Yeah. Yeah. No, no. Go ahead. Okay.
I will take that.
Question is sure Keith.
No no go ahead.
Yes.
So, one of the things, the short answer is yes. The longer answer is that there are few activities that we are doing for innocence. We would like to see the completion and the report of respect to.
So one of the thing.
The short answer is yes.
I'm, sorry is that better.
Okay.
For instance, we would like to see the completion on the report with respect tool as well.
as well as, you know, our ongoing interrogation further of the TREBECA-1 results, first to see whether or not we should continue investigating grasping in pancreatic cancer. Of course, the TREBECA-2 will also inform decisions.
Our ongoing.
Interrogation further of such a big call on Linzess.
You see with our.
Whether or not we should.
Jim You investigate Inc.
Ian Thank you have a cancer of course, the Tribeca store will also inform decision but.
But more globally or more broadly, this is a drug that targets metabolic, at least one of them, metabolic pathways in cancer. And therefore, we have not utilized the full potential of this drug and other tumor types.
More broadly on more broadly of the rock that buckets with appointed Keith.
One of the Amico Pollock costly in cancer, and therefore, we have not utilized the full potential of this drug in other tumor types. So.
As we continue looking at these two immediate clinical activities, and then in the bigger picture, as Eric alluded to, the overall corporate and strategic plans that will give us a better
As we continue looking at the two immediate clinic activities and then in the bigger picture.
I alluded to the over all.
With any strategic plans that will give us a better.
informed insight and decision, which indication to go further with assist grasp, but the story is not yet finalized and it's not yet over with this drama.
Informed inside.
And this was on which indication to go forward there.
Congrats Bob Sterling.
Not yet.
Finalize and is not yet over with this drug.
Jamie.
No I think that could ensue mountain, maybe just to add I think if you ask for smaller indications, but still where the cancer metabolism asparagine glutamine metabolism is known to play a role.
Now, I think that's good answer, Manon, and maybe just to add, I think if you ask for smaller indications, but still whereas the cancer metabolism, the aspargene glutamine metabolism is known to play a role, is, for example, NKT cell lymphoma. And so, obviously, pending further progress with the ALL, but that clearly could be an indication to take an action.
As for example, NK T cell lymphoma, and so obviously spending further progress with the yellow.
It clearly could be an indication to us to take a next step.
in the EMOC, so I mentioned the solid tumor indication, but the EMOC also, we see all of that.
Hey, Mark So you mentioned the solid tumor indications with the mogul so would we see opportunities.
Nice, thank you. I have one more if that's okay. It depends on what would be some of the applications of the Red Blood Cell Vestulation Technology that you would consider pursuing yourself, or is it something that you're considering to make fully available for partnering?
Thank you I have one more if that's okay.
Yeah.
And on what would be some of the applications.
The red blood cell destination technology that you would consider pursuing yourself.
Or is it something that youre, considering can make pretty available for partnering.
It's a real good question and it's still early for us, but for example, we have seen interesting application already in immunocology, like for example encapsulating sting agonist, then vasiculating and really seeing very good uptake by the macrophages.
Good question Ed.
It's still early for us.
For example, we have seen interesting application already in immuno oncology.
<unk> like for example, encapsulating distinct agonist than physical waiting and really seeing very good uptake by the by the macrophages.
obviously still work to be done there, so that could be
Obviously still work to be done there.
So that could be.
depending on how we progress something we continue to do internally for our partner.
Depending on how we progress something we continue to do it totally or partner.
Another application we see clearly in increasing interest and also excitement is if the red cells could be a very good...
With another application, we see clearly an increasing interest and also excited.
<unk>.
The red cells could be very good.
The physicals of Red cells could be a very good vehicle to for example deliver RNA.
The physicals of red cells could be a very good vehicle.
to, for example, deliver RNA. So if we encapsulate RNA in the red cells and then physical aid, this could be a way, for example, for RNA delivery in vivo or in vivo car type of approaches. Clearly, this is something we will not do alone. We don't have the competence. So we're indeed also looking there whether partnering would be an option. See the RNA space is hot, but I hope we can progress there.
So if we encapsulate RNA into red cells, and then physically.
This could be a week for example for RNA delivery.
FIFA or in vivo in vivo car type of approaches clearly this is something we will not do alone we don't have.
The competence of where indeed also looking whether partnering would be an option.
<unk> spaces as hoped.
I hope we can progress there.
Okay. Thank you very much for those answers.
Okay.
And Im showing no further questions at this time I'd like to hand, the conference back over to Mr. Joe Brian for Clos.
And I'm showing no further questions at this time. I'd like to hand the conference back over to Mr. Jill Vayan for closing remarks.
<unk> remarks.
Great. Thank you Norma.
Great, thank you, Norma. Just want to thank everyone for your participation, your interest, your attention today, and for your continued support of Eritech.
I want to thank everyone for your participation your interest your attention today.
And for your continued support of <unk>.
I wish you a great rest of the day and I look forward to speaking again at the next occasion.
Wish you a great rest of the day and I look forward to speaking again than expectation.
Thank you.
This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
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