ERYTECH Pharma S.A.

Thank you, Rudy. Good morning, the people here in U.S.; good afternoon in Europe, [Foreign Language].

I hope you're all well and safe and thank you for joining us for our earnings call for the third quarter of 2020. We announced our business and financial update yesterday evening.

You should be able to access the press release and our earnings presentation on the Investors Relations page of our website. With me on this call today, from three different locations, are Dr.

Iman El-Hariry, our Chief Medical Officer; and Eric Soyer, our Chief Financial and Chief Operating Officer. Before starting, I'm moving to Slide 2.

I would like to draw your attention to the disclaimer on Slide 2 to remind you that today's call includes forward-looking statements such as relating to the company's operations, anticipated timelines, and financials, which involve risks and uncertainties that could cause actual timing and results to differ materially. Although we have been successful at minimalizing the operational challenges caused by the COVID-19 pandemic, we can obviously not exclude that the pandemic continues to have an impact on our trials and operations.

To Slide 3, the agenda standard. I will start with providing the business updates focusing on the key highlights for the third quarter, and year-to-date.

Iman will then take over to zoom in on the status and the progress of the two key trials, TRYbeCA-1 our clinical Phase 2 trial in second-line pancreatic cancer, and on the NOPHO trial, Phase 2 investigator-sponsored trial in ALL, acute lymphoblastic leukemia. After which, Eric will present the financial results for the third quarter and the first nine months of the year, and summarize the major expected milestones for the upcoming 12 months.

And after the presentation, the three of us will be available to respond to any questions. Moving to Slide 4, the company -- just to before starting for completeness, a quick view on the company, leader in red blood cell-based cancer therapeutics and we are focused on cancer metabolism targeting cancer cells altered amino acid metabolism, an area in which we have now late-stage clinical programs in pancreatic cancer, Phase 3, triple-negative breast cancer Phase 2, and acute lymphoblastic leukemia, another Phase 2.

We produce our product candidates in two fully operational manufacturing sites, one in Lyon for Europe, and second one in Princeton for the patients in U.S. And as you know, we're listed on Euronext Paris and on the NASDAQ.

And the graph on the right side is the survival curve of our Phase 2 study in second-line pancreatic cancer, which is with a 40% reduction in risk of death rate 60 to 0.6 hazard ratio to acknowledge the strongest result ever seen in a large clinical trial in second-line pancreatic cancer. And this trial has been enabled us indeed to go to the Phase 3 the TRYbeCA-1 trial, which will again be an important part of this update.

Moving to Slide 5, you'll see there is TRYbeCA-1, but there is more than TRYbeCA-1. We have a pipeline of four clinical trials and three preclinical programs.

For this update, again, we will not have the time to go into everything. We will be focused on the two first arrows TRYbeCA-1 and the NOPHO study.

I just want to take the occasion to congratulate our partners at SQZ Therapeutics -- SQZ Biotechnologies for their successful IPO. We entered into a partnering deal with SQZ a bit more than a year ago in which we granted SQZ IP rights to advance their programs in immune modulation.

And obviously, there's been a lot of success in realizing this. Now, the highlights for us, for the Q3 on the next slide, Slide 6.

I'm extremely pleased and proud of the progress our teams have been able to make on all fronts despite obviously the ongoing COVID-19 challenges. And starting with the clinical programs TRYbeCA-1 first, without taking away Iman's tenure, it's remarkable to see how this large Phase 2 trial continued to progress, coming in on plan, or even above plan, week after week, even over the past weeks with COVID picking up again.

The trial is now very close to complete enrollment and also important to say the number of events that are required for the interim analysis have recently been approved. This means that the interim analysis continues, as we said last time, is still to be expected to take place in the first quarter of next year as we guided previously.

And the next NOPHO, the NOPHO-sponsored IST also continued with no notable impact from COVID and reached the full enrolment a few months ago. We are very pleased with results, yesterday that NOPHO sponsor has been selected for oral presentation at ASH.

It includes the interim data of the trial for the first 36 patients. Iman will provide more detail here.

And by the time of the presentation on December 6, the top-line final data should be available and presented. The other programs, as I said before, are progressing well.

I would like to mention the Phase 1 study in first-line pancreatic. It's an IST also investigator-sponsored trial by the Georgetown University.

Last time, we reported that the trial was ready for launch. Now, site has been initiated and we expect first patients to come in anytime now.

Then turning to the corporate level, I'm excited to announce the appointment of Stewart Craig as our new Chief Technical Officer. Stewart brings 35-plus-years of experience in the development, the manufacturing, the technical operations, quality and regulatory affairs for complex biologics and cell and gene therapies worldwide.

Companies like Orchard, Sangamo, Stemcells, Inc., and PCT. Important obviously because with now two potentially pivotal programs nearing completion, Stewart's deep knowledge in this manufacturing and supply chain will be obviously key as we advance to commercial scale.

On the financial front, also important progress, I'm very pleased. It was announced earlier this week that we have been able to secure a non-dilutive financing €10 million non-dilutive financing in the form of a state guaranteed loan, Prêts Garantis par l'Etat in France, and this is in the context of COVID-19 pandemic.

Eric will provide more details and discuss the implications of this loan plus the other instruments put in place on our cash run rate. And all of this progress together with a lot of activity and achievements for which we don't have the time to zoom in was only possible, thanks to tremendous dedication and efforts of our teams, both in Europe and the United States, who have created a very focused and committed to outcome and mission, the patients, the -- helping the patients to live longer, better.

And I think your patients will thank everybody for this great efforts. And just the patient Slide 7, the patient is the driving factor in everything we do.

We feel the impact we can make as a target -- we feel the impact we can make as we are targeting indications in which there is a real and urgent need for new and better medicines. Pancreatic is obviously a very clear example of this.

Every year, approximately 185,000 patients are diagnosed with pancreatic cancer in Europe and U.S. alone and approximately same number of this people die of this extremely aggressive cancer type with long-term survival, less than 10%.

And we are zooming in for now releasing patients on the second-line complexities. This is about half of the first-line.

So about half of the patients will progress to second-line and in this population, obviously the prognosis is even more dismal. On the other side of the spectrum of the indications it target, ALL on the bottom of this slide, much smaller indication, but still, about -- more than 13,000 patients and I and Iman medicate at least in specific focus.

Asparaginase, as you know, has been an integral component of ALL treatments since many years and it's known that continuing on asparaginase is a key contributor to cure and survival for these patients. The issue is that close to or up to 30% of patients will develop treatment-limiting hypersensitivities to the available asparaginase.

For these people -- for these patients, there is very little treatment options. We estimate it to about 3,500 of these allergic patients worldwide, 1,000 in U.S.

real and emergency needs, and we believe that our product candidate areas will support CrossMark in this indication can indeed make a real difference. That's the importance of this advanced system done in the NOPHO trial.

But in the ALL pancreatic cancer, we have shown in previous trials as proof of concept in multiple clinical trials. We are now also bringing this forward to other tumor types and TNBC, triple negative breast cancer is the next one which is the Phase 2 proof of the trial is ongoing which also very important unmet medical needs with about 15% to 20% of all the breast cancer in this triple-negative category.

And then beyond pancreatic, ALL, TNBC, there's a broad range of high unmet needs solid and liquid tumor types that are known to be asparagine and glutamine dependent and for which the therapeutic window of the current non-encapsulated asparaginase is the use and agility -- utility and for which indeed we believe that CrossMark at least in our space can be very beneficial to these patients. So up to here, the business updates, and I'll now turn the call to Iman who will provide more detail on how we are addressing these medical needs and the progress we're making from our trials.

Iman, the floor is yours.

Okay. Thank you, Gil.

Good morning. Good afternoon, everyone.

As you know, I'm starting on Slide 9. This is just a quick recap on the TRYbeCA-1 clinic trial.

So this is the trial in second-line pancreatic cancer made by Professor Hammel and Hidalgo in France and United States. The study is approximately 2,500 patients in second-line sitting, comparing and evaluating it as far as instead of improving overall survival when added to standard of care chemotherapy.

The chemotherapy in this trial is [indiscernible] gemcitabine and abraxane or irinotecan/onivyde for chemotherapy. And that's clearly dependent on what patient received in [indiscernible].

The trial was launched as you may recall end of 2018 and we are over 95% of physicians involved in the trial in 20 countries including United States. So this trial is overall survival and we are looking for an improvement in hazard ratio of 0.725 with additional Eryaspase as investigational agent and the study is specified based on sciences diagnosis of advanced disease, performance status, as well as the backbone at chemotherapy.

Turning on to Slide number 10, just to give you the quick timeline. We are really very pleased.

We are more than 95% enrollment in this trial and so we expect to complete the study enrollment before end of this year almost immediately. [Indiscernible] is that we have accrued the number against required for the interim analysis and, as Gil mentioned earlier, we are on target for our interim analysis in Q1.

You may recall also that we have had three safety reviews by our independent data monitoring committee and the last one was conducted based on the data from the first 320 patients in the study. And where we are today, intensive patient analysis planned in Q1 '21, our data cleaning is taking little bit of more time given COVID-related challenges, as you know.

But more importantly, there are two possible outcomes in this interim analysis. There is no futility to this, only superiority analysis due to the accompanying evidence of improvement of overall survival is additional [indiscernible].

If the [indiscernible] doesn't key enough evidence in that -- in the interim and that we would continue to completion as to the final analysis and again we are projecting this will be in the fourth quarter of 2021. So switching to the next slide, Slide 11, shifting gears to the NOPHO trial, which is a new interesting study for us.

The NOPHP trial is an investigator-initiated trial of a certain asparaginase in patients who have developed hypersensitivity reactions to trial and asparaginase and specifically Oncaspar is articulated in asparaginase. The good news is that the study not only completed enrollment of the 55 patients but also they -- the patients completed treatment.

The last patient in the study completed treatment two weeks ago. This study is made by the NOPHO group, which is very renowned oncology group, hematology oncology group in Europe.

We are pleased that the study has been accepted for an oral presentation at ASH and that will be on the 6th of December of this year. But I'd like to take you and point you to the next slide, Slide 12, and this is why we think we -- in it we have a solid case as far as an approval.

This slide will give you the top-line results based on that [indiscernible] that was published by ASH. And so, as you see on this -- in the first 36 patients the asparaginase activity was actually in almost all patients.

And not only that, this was also [indiscernible], but of interest, when you see that these results show typical similarities to what was reported in the Erwinase clinical trial, that is the basis for an indication of hypersensitive patients in the United States and based on 58 patients in total. Where we are today we believe that patients with hypersensitivity actions to prior asparaginase therapy presents unmet medical needs given the ongoing shortage, and therefore we believe that there is a need to develop alternative asparaginase formation to the patients.

And why is that is because there are several publications to show that transmitted asparaginase therapy would have an adverse impact in the patient outcome particularly event free survival and overall survival and to develop applications not only in asparaginase, but also tools in applications one of them in this or this year in 2020. So providing that the full data which will be published and presented by the industry at ASH are in line with what we think in abstract, we will have further discussion with the FDA and this is where we would like to determine whether we have a potential path forward in that institution.

And I think this concludes my slide and I would turn over to Eric to provide an update on the financial results of this quarter and various financial activities and cash position. Over to you, Eric.

Thank you, Iman. And good morning, everyone.

We're now reviewing the financial highlights for the first nine months of this year and actually, we're on slide 14 of the slide deck. And starting with P&L information.

Net loss for the first nine months of 2020 was €53.6 million, was up €10.3 million, or plus 24% year-over-year with a €4.7 million increase or 7% in operating loss and the €5.6 million decrease in financial income. The €4.7 million increase in operating loss was attributable to a €6 million increase in preclinical and clinical development expenses, mostly related to expenses for the company's Phase 3 clinical trial in pancreatic cancer.

Also a €2.3 million decrease in G&A, which was related to the [indiscernible] related to establishment of the manufacturing capacity, which was mostly incurred in 2019. And a €1 million decrease in income, of which €0.9 million consisted in the upfront payments from the June 2019 license agreements with SQZ Biotechnologies that did not, of course, recur in 2020.

We're now moving on to Slide 15 for comments on cash. Starting with the cash position as of September 30, 2020, ERYTECH had cash and cash equivalents totaling €40.5 million which is approximately $47.5 million, and that's compared with €73.2 million on December 31, 2019 and €45.4 million on June 30, 2020.

The €32.7 million decrease in cash position during the first nine months of 2020 consisted of -- consisting of €14.6 million in the first quarter of 2020, €13.1 million in the second quarter, and €4.9 million in the third quarter. And that was the result of €32.2 million net cash utilization, which was mostly comprised of a€38.2 million net cash utilization in operating activities, v1.4 million used for investing activities, and €7.4 million generated in financing activities, while the depreciation at the end of the period of the US dollar against the Euro led to a €0.4 million negative currency exchange impact.

And now a word on our most recent financing initiatives. And we're now on Slide number 16 of the presentation.

First, you remember that so we signed financing agreements in June each year with Alpha Blue Ocean in the form of convertible notes, and as of today, we've called two tranches of convertible notes of €3 million each one in July and August 2020 for net proceeds of €5.6 million and as of today, all the notes have been converted. Also, in September, we also announced the implementation of an at-the-markets or ATM equity financing program in the US with Cowen.

The shelf registration statement on Form F-3 that was filed by the company to cover the ATM program was declared effective by the SEC on October 9, 2020. And to-date, the company has not sold any securities pursuant to the ATM.

And earlier this week, we've announced that we have secured with Bpifrance and Société Générale the €10 million non- dilutive financing in the form of a state-guaranteed loan and that's called a PGE loan. Each of Bpifrance and Société Générale will provide ERYTECH with a loan in the amount of €5 million and the French government will guarantee 90% of the total amounts due under the loans.

The loans will bear interest at a fixed rate of 1.75% and 0.25% per annum respectively, with an initial term of one year. And at the end of this initial term, the company, at its option, may defer repayment of the principal amount over the five-year period.

We believe that the €10 million state-guaranteed loan, in combination with its current cash and cash equivalents, will extend its cash horizon into Q3 2021 and when taking into account the potential proceeds under the convertible bonds financing and the ATM program, the horizon could be further extended until the end of 2021. And finally, we're on Slide 17, a quick wrap up of the upcoming key milestones.

And we should say that, after a few years of dedicated execution, and through a little news flow, 2021 announces to be a year with multiple important catalysts. I would like to start with the bottom of the page as in chronological order.

Our next expected key milestone will be the final results of the NOPHO study the Phase 2 study in ALL patients who develop hypersensitivity to pegylated asparaginase. We've already provided financial updates on this trial last June and I've explained that a few minutes ago, most of the abstracts was interim data of the first 36 patients have been accepted for oral presentation on December 6 at ASH and by that time, we should have topline final data available and presented.

If these data are in line with what we've seen so far, and we're subject to the ongoing dialogue with the FDA continuing to go in the right direction, we may be in final mode early next year in this indication, ALL indication in view of filing the BLA as early as mid-next year. Next, and we're back to the top of the page is the TRYbeCA-1 with Phase 3 study in second-line pancreatic cancer.

As already mentioned, with no more than 95% of patients in the trial, we expect to be able to complete enrollments in TRYbeCA-1 before the end of this year. Then the next key milestone in the study is interim analysis for superiority [indiscernible].

We expect this interim results in the first quarter of 2021, then again two possible outcomes, either we can conclude early for superiority if the primary survival endpoint is already met with only two-thirds of the events and in which case we would then be able to move -- it will lead to a BLA and a MAA filing or we continue towards the final analysis, which, as you know, is expected in the second half of 2021. And finally, a word of the two of the trials.

First is the initiation of the Phase 1 study in first-line metastatic pancreatic cancer. This will also be an IST trial in the U.S.

with the Georgetown Lombardi Cancer Center and we expect to start patient enrollment before the end of this year with results before the end of next year. And also the continuation of the TRYbeCA-2, the Phase 2 study in triple-negative breast cancer where we expect results towards the later parts of 2021.

With that, I would like to thank you already for your attention. I will now open the call for any questions you may have.

Again, I would like to remind any of you who would like to ask questions in French that you're, of course, very welcome to do so. [Foreign Speech].

Operator, Rudy, that's over to you. Thank you.

Hi, this is Justin Walsh on for Reni. From our discussions with KOLs, if Eryaspase does well in second-line pancreatic cancer, there's a lot of interest in moving into first-line or maintenance treatment or even looking at potential combinations.

So I know that you have the Georgetown investigator-sponsored trial, that's just starting. I'm wondering what your potential development plans would be beyond that if TRYbeCA-1 succeeds and Eryaspase is approved in second-line?

Thank you, Justin. Gil here.

I'll start with an initial answer and let Iman complete it. So it's a very good question indeed.

The first-line, we also feel is interested, obviously subject to positive confirmational data in second-line and, yes, the Georgetown study is an interest that there we realized and this was the feedback we got from, for example, the [indiscernible] group to Southwest, saying, well, very interesting. But before you can go to first-line, as FOLFIRINOX is gaining so much ground in first-line, it would be important to show safety in combination with fulfillments.

And so that's the whole idea to do this in Georgetown in a dose escalation study. And then it is for first-line, but, for example, also if we feel and hear a strong interest like for locally advanced setting, where also same idea that this FOLFIRINOX combination being so important.

So, yes, I don't know, Iman, whether you want to complement on this?

Yes. So Gil you mentioned to measure through indication that we are considering moving forward beyond the second-line setting.

But also there are other niche indications that we would like to really have some discussions with [indiscernible] including the maintenance therapy and the rationale for that is, we have shown that Eryaspase can be given for a longer duration of time with a good level of tolerability and safety, so to maintain a certain is an indication on our [indiscernible]. Also and other indications that we are considering, and this is really based on the physical side.

If you remember, the physical trial tested gem monotherapy with or without in excess and also we have shown a heightened benefit if it's overall survival, protective response, sleep, et cetera. And so we believe that there are subsets of patients who would not be eligible in real life to receive a gem/abraxane chemotherapy and, therefore, they are only eligible to receive gem alone to believe maybe perhaps a poor performance in these patients -- I mean the Phase 2 of [indiscernible] Phase 3.

This could be eligible for an indication and that we are particularly interested in this one, because most clinical trials in pancreatic cancer and in particularly second-line pancreatic cancer, performance data, two or three are excluded companies like ours like others. And, therefore, this presents a true unmet need for those patients.

So these are the highlights, but we also are looking [indiscernible] sub combination to get us some support at trial [indiscernible] support at trial that can be an ultra niche indication that we would like to ask this in a small pilot discussion.

Thank you. That's very helpful.

And just a couple more. You mentioned that you did ongoing discussions with the FDA with respect to ALL.

I was just wondering if you have a specific meeting that's already planned to discuss the full NOPHO results. And if you've received any feedback from regulators beyond them saying that there's an unmet need in patients who have an allergy to asparaginase?

Iman, you can also take this question.

Yes. So if there's a NOPHO trial, we will once we have the trial results published at ASH in that representation, we will be planning to share this information as well as other internal data is around the [indiscernible] and, of course, that will determine whether it will give us the green light to proceed for a [indiscernible] meeting.

But I can actually confirm that the unmet medical need in that indication has been confirmed by the FDA.

Perfect. Thank you.

And then the last question for us. Just wondering if there are any specific dates when we can expect to see some more preclinical data out of the Erwincynaze or Erizine [ph]?

I know the focus is, of course, on the clinical work, but the platform is still very interesting and I was seeing more data there.

And good question, Justin. Indeed we have for -- the clinical trials have, sort of, overshadowed all the work we're doing in preclinical, but we're continuing to do interesting work there in unmentioned combinations.

That's really the view of life cycle management still more related to grasp up to Eryaspase. The [indiscernible] program in fact pre-clinically we're ready there.

We've done the proof of concept, the preclinical proxy, it's now -- we're waiting for additional momentum created by the clinical trials so that we can financially secure Phase 1 study. So there's still some work ongoing for the supports, like also combinations with erimetinase [ph] with some other components -- compounds.

Of the Erizine, there's different things ongoing, we're still working on our arginine deiminase, and there should be a publication coming out not too long from now. It's been difficult to get it out, but it should come out.

And, yes, I think it's a good suggestion or a good idea that, sort of, not put it in attention. But I hope some, say, first half next year that we should dedicate one of these calls more to what we have -- what we are seeing in the preclinical context.

I've got a couple of questions if I could, please. So first of all, I was just wondering in terms of the interim analysis.

So now that you have the events accrued, and you're talking about getting the outcome of the analysis in the first quarter, could -- is there a chance that that could come sooner than that? So could we actually see it before the end of this year?

And then my second question, we've seen regulators quite focused on CMC, particularly for these more complex therapies. What could you say in terms of how ready you are in terms of having all the CMC data that you need such that if the trial is positive at the interim, that you could actually proceed to filing quite rapidly and you have all the CMC data that you need to enable that?

Thank you.

Thank you, Philippa, and good afternoon. And I also will leave this to the Iman because it's really in her fields.

I think she's been disconnected and she's trying to reconnect.

Yeah, yeah, sure. So for the inter -- yeah, the events are accrued.

And instead of normal times, there would be a chance to communicate before the end of the year, given COVID, sort of, if we say COVID has had very little impact on the trial enrolment, and not on the events, obviously, that's where we see the impact is on data cleaning, and because the access to the site is limited. So that's why we need the reason that we say Q1, because there is an uncertainty around the around the -- it's taking longer than expected.

So I'm saying no possibility to have it before the end of the year. And on the CMC question, indeed that's the key one in all these therapies, I know it's in since always, in cell therapy.

We have had an -- we have also there an ongoing dialogue. We had in the summer had the questions, the CMC meeting, with the meeting with very good interaction.

And so we're progressing very nicely to address all the different points there. Obviously, we have now almost 15 years experience with this product in different settings and combinations.

And also there, the recruitment of Stewart has been a key milestone. He's been effectively recruited -- he joined us in early November, but he's been working with us over almost a year now, in view of indeed, making sure we're completely ready on the CMC, GMP, operational, technical operational readiness.

And so I'm confident that we're taking the right steps, there for the CMC does not become, sort of, and sort of delay in the potential approval for us.

Hi, good afternoon, everyone. Thanks for taking my questions.

I have a couple of questions, if I may. I think first of all, for the ALL data that was just sent to ASH, we already saw the extracts coming out with the description of the asparaginase enzyme activity.

And they do mention a couple of thresholds, they mention is that a couple of patients or above 100 and [indiscernible] a couple of questions [indiscernible] seems the leader, but also for you to give us some color on what that means in terms of the clinical benefits for them and how should we be looking at these numbers and at this data?

I'll start here also, and then give over to Iman. It's through that, sort of, asparaginase over like Erwinase has been approved in the past about this demonstration of activity above the threshold of 100.

100 has been the threshold also for other approvals. 400 is for information also mentioned, like the Oncaspar approvals, 400 was more like secondary endpoint.

And so that has only asparaginase. It's so well-established now since asparaginase have been on the market since the '70s, that if this activity can be maintained over this threshold of 100, that will lead to clinical benefits has been demonstrated.

So that the trials right now are -- it's, sort of, the dispatcher activity is an established surrogate endpoint for asparaginase. And the clinical benefit like we have seen in our Phase 3 trial which was randomized, was clearly related that we have this almost level, complete response, objective response and for the survival.

Here in the local trial it's is a single arm study that will be clinical data, that it's difficult to establish the clinical benefit compared to the comparator. So it's really an activity endpoint and a safety endpoint and, yes, answered it completely.

I don't know. Iman, do you want to add to this answer?

The only additional comment I would like to addressed, Ingrid, is that the asparaginase activities, the whole point about assessing the level of asparaginase in the system because asparaginases are known to develop not only the high pressure [indiscernible] but what is called solid inactivation. And so you may have, if you start to see these it is dropping that it means that you're giving the drug, but it really virtually doesn't have any effect from a thermodynamic or clinical benefits.

Now, why this is -- I mean, why asparaginase activity is established, sort of, the endpoint as in FDA and other agencies, we -- it is expected that if you achieve that level or that threshold, you would expect to have clinical benefits for asparaginase. So and that's what different science randomized clinical trials with different asparaginase in particular Oncaspar have shown.

So that is why. On the 400, 400 is more of a sensitivity analysis to show that, can you even achieve higher levels in case that the [indiscernible] started to drop, with the development of silent inactivation or antibodies, neutralizing antibodies.

And therefore, it is a sensitivity and for nothing more, but that critical number that one needs to focus on is the 100 unit per liter as a threshold established by the agencies.

Well, thank you very much. It was really helpful and makes a bit clearer for us.

And if I may, just a second question maybe for Eric. So which one was Alpha Blue Ocean.

Can you give us a little bit of color and guidance from when you are actually planning to draw some additional tranches of the loan? What are some considerations that we should keep in mind that would trigger you to draw this next tranches?

I -- Ingrid, well, what would not make any decision, yes. As you know, this is our selection to do the next tranches.

True that this PGE loan has given us some extended runway. So we'll see what the market conditions are, these -- there's no decision yet.

Okay. Thank you for taking my questions.

I ask from my side, mostly on [indiscernible] and the ALL. Jazz is currently running a Phase 2 study of another -- studying more than 100 patients in the new combination of Erwinase.

How confident are you that 55 patients could be sufficient to find in the U.S.? And I don't know the proportion of children among the 55 patients.

That could be restricted to two children only. The second one is also has to do with Jazz and Erwinase because we know that the Jazz is struggling to supply Erwinase.

Recently the French medicine agency issued a new report guidance on how to address these. Do you think at the end that it can be helpful for you to convince regulators to approve areas and instrumentation especially in children knowing that this issue is with [indiscernible] is a major concern for people?

And the last one is on the market access and the pricing. I'm curious to hear you because potentially you make sure you could file the same project at a different dose regiment in two different indication, pancreatic cancer and ALL.

So how we should see, how we should think about the pricing and do you see that -- do you think we can have an impact on pricing knowing that you could be unpredictable to two different indication? Thank you.

Thank you, Eric. So also here I'll start.

Yes, Jazz is working on new Erwinase. So the trial is ongoing.

It's a trial up to 100 patients but they have added that there may be filing based on the interim 50 patients. It's as I answered maybe that before, I think, yes and we should we take this into account that there will be some other Erwinase one day, but given the fact that this is such and -- given the experience now with all the shortage so Jazz was able to supply only one day in the third quarter.

So it's been a really painful periods of last two years. So the fact that's has made, I don't know, suggest but there's this is unmet medical needs and you also know what's -- what is ongoing.

So I think the unmet medical need will stay that we also have to keep in mind the Erwinase product is a product with half a day shelf life but -- half life, sorry. So need 12 injections per month, it crossed out two injections per month.

So there's also these, these other aspects to take into account. And is 55 patients enough?

So that's really the dialogue with the FDA. So the Jazz Erwinase product, current Erwinase product what's the -- performed with 58 patients plus then a broad program of compassionate use and, sort of, real life experience, we will have specifically as 55 patients, but also broad program of experience in ALL, in number of events, it is really close to 150 to 180 patients in ALL, present the safety database pancreatic.

So there is a whole basis there that we think given the unmet medical needs that, yes, we are hopeful, but it will all depend on the data and the dialogue that we will have. And it is indeed, the 55 is essential in pediatric surgery, almost all pediatric.

It is a NOPHO, the Nordic Society of Oncology and -- Pediatric Hematology and Oncology. So but there are some young adults in there also.

And just I'll continue on this the -- it's to all of this dismiss the shortages in France, you mentioned that it's in the U.S., it's in other countries. So clearly, that's where we see look above the convenience aspects, the opportunity and the possibility to address this real unmet medical need, and hopefully, we'll get approvals in them.

So those first interactions are in U.S., but if that's encouraging, we will entertain also the dialogues in other territories. And then on market access and pricing, yes, it's the same product in two indications.

And where in the ALL and this may be the benefit if we could get an approval in ALL before like we had because in ALL there is appeal pricing reference. Erwinase is very expensive product as you know.

So with a very clear pricing reference in pancreatic [indiscernible] that this is also one of the reasons why I'll try so important. There is really nothing in pancreatic cancer except for chemotherapy, and the only product, but there's no real pricing reference compared to a product like ours.

So this will be a very difficult subject the clearly the pricing and investment we think that the ALL can have and to create the reference that is missing in the pancreatic. So I answered probably a lot of but also again, I will ask Iman to complete aspects I may have forgotten.

And thank you, Gil. I know for [indiscernible] Gil her addressed it all, I think I would like just one point to add here on our level of confidence that I want to, thinking about tier a single ARM trial versus an ongoing randomized trial on the Jazz.

It's -- we need to look at things in totality. So while this study is 55 patients in total, and if there is a positive dialogue with the agency, we'll be going to potentially to ideally with a data -- the 60 database of over 600 patients.

And that is really critical from a benefit/risk ratio when the agency assess the validity of this trial. So it will look -- this would be an important trust factor to consider in addition to the 55.

And yes, the majority of the patients are pediatric. And again, that would be its -- it would be subject to the dialogue with the agency.

Lucky, yes, I am aware of the guidance that actually came out, I think, a week or just a little over a week ago in France regarding the Erwinase. And as you mentioned, we'll open that door when we first assess the validity of the approaches to FDA, then go to the [indiscernible] and then, of course, that can enable us if you're in a sufficient mode to go into the cohort, as you know.

Thank you. Just one quick question and one observation.

Do I understand it correctly that if the pancreatic trial is positive, that you would file simultaneously in the United States and in Europe? And just another one, Gil, on when you just commented about the pricing situation, as the EMA has this parallel transaction where you can talk about the HDA issue at the same time as the clinical issues that might add some aspect to your pricing considerations?

That's just a thought.

Thank you, Victoria. A long time we -- since we spoke, so nice.

So, yes, that's the current thinking, it leads to the trial, the HD trial is run in Europe and in U.S., so 11 countries in Europe and the U.S. And, yes, it's the plan and the teams are gearing up for a simultaneous, maybe fully synchronized but close to seems simultaneous filing both in Europe and in the U.S.

for pancreatic. And thanks for the suggestion on the hint on the pricing.

It's true that there is -- we -- the work is literally ongoing now. So to really think on the different strategies and options and then I'll take this one clearly into account.

Thank you. I want to thank everybody for the participation, the attention, the great questions and for your continued support of ERYTECH.

We as always will keep -- look forward to keeping you updated on the progress through the remainder of this year. One of the next locations will probably be those participating at the Jefferies Conference in November.

Hope to see you there. Thanks again for joining and wish you-all a great day.

Thanks everyone.