Good day. Thank you for standing by. Welcome to the ERYTECH business update and financial highlights for the first quarter of 2021. At this time, all participants are listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you 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. I would now like to hand the conference over to your speaker today, Mr. Gil Beyen, Chief Executive Officer. You may go ahead, sir. Thank you, Dexter. Good afternoon. Good morning. Thank you for joining us for our first quarter 2021 earnings call. I hope everyone is well and safe wherever you may be. We announced our business and financial update yesterday evening. I hope the press release and the Q1 earnings presentation can be found on the investor relations page of our website. Joining 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. We are on three different locations, there's some technical issues, I hope that Iman can join us in the meantime. In the meantime, before starting the update, I draw your attention to slide two to remind you that today's call includes forward-looking statements such as relating to the company's operations, timelines, and financials. As you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially. Switching to slide three, the agenda. As usual, I will start with a short introduction and indicating the key business highlights for the quarter. Iman, if she's able to join in time, will then provide an update on the status and the progress of our four clinical programs. After which, Eric will present the financial results for the quarter and highlight our most recent financing from last week. He will also summarize the expected milestones for the coming year before we open up the lines for Q&A. All three of us will be available for your questions afterwards. Now moving to slide 4, and as a quick reminder for anyone new to the company, ERYTECH, the name tells it, erythrocyte technology, is the leader in red blood cell-based cancer therapeutics. Our focus is on targeting cancer cells' altered amino acid metabolism, an increasingly important and exciting area of cancer therapy. In this area, we have late-stage clinical programs in pancreatic cancer, triple-negative breast cancer, and acute lymphoblastic leukemia, ALL, as you can see from the pipeline chart on the right-hand side of the slide. I mentioned it at our call in March, 2021 is indeed truly a key year for ERYTECH. All four of our clinical programs are expected to report defining events before the end of the year, two of which potentially supporting the application for regulatory approvals within the next 12 months. More on that in a minute. We do the encapsulation of the APIs, the asparaginase, in the case of the lead product in our manufacturing sites, fully operational facilities, one in Lyon for Europe and the second in Princeton, New Jersey for the U.S. Last point also on our really U.S.-Europe company, not only are we present both in Europe and in U.S., we also are listed both on Euronext and NASDAQ, we have a shareholder base, which is approximately half Europe and half U.S. This as a short introduction. Going to slide five, the highlights of the quarter. Indeed, it's continuing the progress that we've made in 2020. 2020 was really a year with a lot of achievements on the different clinical programs. This first quarter has been an important one with important steps forward towards bringing eryaspase, our lead product candidate, to patients, and this both in Europe and the U.S. There's four highlights I'd like to mention briefly. Iman and Eric will zoom in more in detail. The first part, obviously, on TRYbeCA-1, our pivotal phase III trial in second-line advanced pancreatic cancer. We completed enrollment actually in January. We had almost completed in December, but there was two more patients coming in January. Now 512 patients randomized. In February, we had our interim analysis. Interim analysis performed by the trial's Independent Data Monitoring Committee, the IDMC. This one, there had already been three safety-only reviews, all three with good safety profile and recommendations to continue the trial without modification. This one was safety and efficacy combined, and also here, the recommendation was to continue the trial without modification. Now the eyes are really on the final analysis, which we continue to expect in the fourth quarter of this year. With this, indeed, the eyes really on this trial. TRYbeCA-1 is, to our knowledge, the largest clinical trial ongoing in second-line metastatic pancreatic cancer, and obviously has the potential, if successful, to lead to a treatment paradigm shift in this horrific disease. TRYbeCA-1, that was first. Second, staying in pancreatic cancer frame from the IST, the investigator-sponsored phase I trial in first-line pancreatic cancer, a trial we're doing in view of bringing our lead product also to first-line pancreatic. Obviously, after confirming the result in the second-line. This trial, it's an 18-patient standard dose-escalating trial, started enrolling in January and completed the first dose cohort of 3 patients, in fact, in March. In April, there was a review by the trial steering committee. No dose-limiting toxicities were identified, and on top of this, very encouragingly, a nice signal of clinical activity was observed. 2 of the 3 patients showed a partial response, and the third patient, a stable disease. The investigator, Dr. Marcus Noel, very motivated about this trial. Already, we moved it now to the second dose, and Iman will explain a bit more about this. Third clinical highlight is on ALL. The fact that we took a next step in our path to seeking approval in ALL patients who develop allergies and hypersensitivities to pegylated asparaginase based on the phase II data of the NOPHO-sponsored trial that was communicated at the end of last year. Following further interactions with the FDA, we now requested a pre-BLA meeting, this was last month, mid-last month, to discuss a potential submission of a BLA, of a biologics license application. Subject to the feedback from that meeting, we plan to submit such BLA in the second half of this year. That's on the highlights on the clinical, clearly there was also last week, the fact that we raised EUR 30 million in a registered direct financing. Eric will provide more detail in a few minutes. Moving to slide six. The summary here is that indeed all of this sets the stage for a catalyst-rich remainder of the year, as you can see from this slide. I will not repeat what I said earlier, but you see the green check marks that marking the achievements over the past 6 - 9 months, and then the 4 clinical tracks that we'll now have are well-positioned for significant and defining milestones in the coming 8 - 12 months, with two of them holding the potential for regulatory approval submissions in that time horizon. I will stop here with the introduction, and hand over to Iman, if Iman was able to join in the meantime, to provide more color on the 4 clinical programs and their expected milestones. Iman, can you- Yes. Yes, good. Hi, Gil. I'm here, and I hope you can hear me okay. Yes, it's good. Okay, fantastic. Thank you. Good morning. Good afternoon, everyone. I'll just really quickly on the highlights from the clinical program and just add a little bit of color to what you just said. Starting with eryaspase, and as a reminder, this is our phase III trial in second-line pancreatic cancer led by two PIs, Pascal Hammel in France and Manuel Hidalgo in the United States. The study is an overall survival study that's intended to enroll about 512 patients above 18 years of age with good performance status in a second-line setting and were randomized to receive chemotherapy with or without eryaspase. The chemotherapy was a minimum of two, either irinotecan-based chemotherapy, the generic irinotecan, or oxaliplatin plus folinic acid. The second line of choice was gemcitabine, ABRAXANE. We had the primary component of overall survival. The second endpoint included, naturally, the progression-free survival and objective response, which is controlling. We are also looking for quality of life. We have been collecting tumors again as tissue materials planned for extensive biomarker and translational research after the study is reported. In fact, it was a global trial in Europe as well as in the U.S. Moving to slide number nine. As you mentioned, we enrolled 700 patients. End of last year, we had four IDMC, two of them with safety IDMC meetings, and the fourth one, which was conducted in February of this year, where the IDMC recommended to continue the study without modification. [audio distortion]. At this stage, our operational team, in conjunction with the CRO, are working with [audio distortion]. We have been within the regulatory review. All of this operational work is currently ongoing to be able to report the study as planned in the first quarter of this year. Staying with pancreatic cancer and moving to slide number two. This is the initiative trial in front-line setting, made by Marcus Noel in Georgetown. The study is a phase I dose escalation study, and we had minimal number, of course, in the trial. We started at 75 units per kg of eryaspase in combination with modified FOLFIRINOX. As you mentioned, that cohort completed no issues, interesting clinical attention. We recommended the study to escalate to the next cohort at 100 units per kg. The study is ongoing at this stage. Being given that interest and the progress of first line, we would expect that they will be able to identify the maximum tolerated dose sometime in the second half of 2021. Once the maximum tolerated dose is defined, the study will extend. I think now the current plan is to do an expansion cohort up to 18 patients. Again, of course, we are in continuous discussion with our investigators, Dr. Marcus Noel, whether that expansion cohort should be modified slightly. Moving to keeping this to a different indication, triple-negative breast cancer. This is a study actually originally planned in first line in triple-negative, and the study is led by [audio distortion]. With that, actually recommendation from our investigators, we decided to include second-line setting. This study now is open for both first line and second line. That reflects the change in the standard of care, particularly, of course, in 2020 with introduction of [audio distortion]. As you have seen that a few weeks, over a week ago, we are now being invited to meet with the FDA in a pre-BLA meeting to discuss the potential of being sufficient. [audio distortion]. With this, and as you know, of course, the asset indication, again, it's important to highlight a couple of critical points. With continuous shortage worldwide, certainly there is an unmet medical need for an option for patients to receive an additional asparaginase treatment in who receive either ONCASPAR or any other asparaginase in the first intention for this disease. That's the first point to highlight. Excuse me. The data that we have in this trial was supported last year, in fact, compares very favorably to the data that was the basis for approval back in 2011 in the United States. Number three, we believe also not only the data on this trial, but also we have a distinct pattern with a larger patient database. We have consistent pattern of asparaginase activity in our program. All in all, we believe actually that we have an additional data package to support this trial. Again, that would be part of the discussion, in our upcoming meeting with FDA. To this end, I will stop here, and I will hand over to Eric to walk us through the financial results of the first quarter and then Q2. Eric, over to you. Thank you. Thank you, Iman. Good morning, everyone. [Foreign language]. We're now reviewing the financial highlights for the first quarter of this year. We're on slide number 14 of the slide deck, we're starting with the P&L information. The net loss for the first quarter of 2021 was EUR 11.9 million, which was a decrease in net loss of EUR 5.6 million. It's -32% year-over-year, with a EUR 5.8 million decrease, -31% in operating loss, a EUR 0.2 million decrease in financial income. The EUR 5.8 million decrease in operating loss was attributable to the EUR 4.8 million decrease in preclinical and clinical development expenses, that was concurrent with the end of patient enrollments in the company's phase III clinical trial in pancreatic cancer. A EUR 0.3 million decrease in G&A, a EUR 0.7 million increase in other income, which was mostly related to R&D tax credits. In the meantime, the EUR 0.2 million decrease in financial income was mostly related to the IFRS accounting of the convertible notes. We are now moving to slide 15 for comments on cash. As of March 31st this year, ERYTECH had cash and cash equivalents totaling EUR 37.4 million, which is approximately $43.9 million, and that is compared with EUR 44.4 million on December 31st, 2020. This was a EUR 7 million decrease in cash position during the first quarter of this year, and that was the result of a EUR 7.6 million net cash utilization, which was mostly comprised of a EUR 16.4 million utilization in operating and investing activities and EUR 8.8 million generated in financing activities, while the variation of the U.S. dollar against the euro led to a EUR 0.6 million positive currency exchange impact. The financing activities in the first quarter of this year included EUR 6.4 million to the company's at-the-market or ATM equity financing program. It was a placement with a top-tier U.S. investor specialized in biotech. A EUR 2.9 million net proceeds from the drawdown of one tranche under the convertible note financing agreement, which is also called OCABSA, signed with Alpha Blue Ocean last year. Now a word on our most recent financing initiatives. We're now on slide number 16 of the presentation. As you've seen and already mentioned by Gil Beyen, we've announced last week a new round of financing, and more specifically, a registered direct offering of $30 million placed with specialized healthcare investors, mostly in the U.S., but also partially in Europe. This financing involves the placement of new ordinary shares that are in the form of American Depositary Shares, ADS, and each ADS was subscribed at $7.25, which is EUR 6.01. The ADS were also associated with a 75% warrant coverage. The warrants have a two-year maturity and an exercise price of EUR 7.50, which is US$9.05. We're of course extremely pleased with this important financing milestone for ERYTECH and the mark of confidence in the company's upcoming developments. The net proceeds from this financing round will further strengthen the company's financial position with a cash horizon beyond our anticipated key catalysts. At this stage, we believe that the company's current cash position, including the net proceeds from the last week's offering, can fund or plan operating expenses and current programs into the first quarter of 2022. This cash runway could be extended into the third quarter of next year if the company further utilizes the OCABSA agreement, of course, subject to the usual regulatory dilution limit of EUR 0.20. Finally, moving to the next slide. That's number 17. I wanted to quickly summarize the upcoming key milestones before starting the Q&A session, all this was already covered extensively by Gil and Iman. Starting, of course, with the final results from TRYbeCA-1, that's the phase III trial, in second-line pancreatic cancer. As explained, those final results are expected in the last quarter of this year, Q4 2021. Obviously, a key milestone for the company. Before that, potentially, a potential BLA filing with eryaspase for ALL. Iman has explained, Gil has explained the regulatory work on that front, that could be expected in the second half of this year. We also expect the first result from TRYbeCA-2, the randomized phase II trial of eryaspase in TNBC, triple-negative breast cancer. That is expected by the end of the year, so Q4 of this year. Finally, there is the determination of the maximum tolerated dose in respect. That's the phase I in first-line pancreatic cancer. That's an IST. This is expected in the second half of this year. Again, a rest of the year, which is full of potential and quite exciting catalysts. With that, I would like to thank you already for your attention. I will now open the call for any questions you may have. As always, we'll also welcome the questions in French, if any. Operator. Dexter, it's over to you. Dexter? Your first question comes from the line of Reni Benjamin from JMP Securities. Your line is open. Hey. Good morning, guys. Thanks for taking the questions. I might have missed this in Iman's comments, I apologize if you guys have to repeat it, but what was the initial clinical activity that was observed in the IST front line study? Is there any way to kind of tell why that response might be more or less due to the addition of eryaspase versus not? Hi, Reni. Good morning. I'll start. Iman, you go. Okay, go ahead. I'm having an issue. If your line is- I can hear you. Iman, maybe I'll start because your line is really weak, and then you can add if I forget something. Basically, Reni, the initial clinical activity was two partial responses of nice partial responses and a stable disease, so 100% disease control. Which it's only three patients, obviously, but still it's encouraging. It's pancreatic cancer, and so that was really the message, at least. Maybe, Iman, you want to add to this? Yes. Can you hear me? Yeah, it's a really tough connection. Really not well, no. Yeah. What about duration, Gil? That is pretty promising, but anything regarding the duration of these partial responses? This was the partial response, obviously, soon after the treatment, so it's the first. I don't think there is much view on duration yet. Iman, is there a view on duration of these partial responses? Not yet. The initial assessment was eight weeks after the first dose of IST. At least the minimum we have the first eight weeks, but we don't have the duration. It will continue until you have the disease progression. At that moment, we have the steering committee. We don't have really the full details around the duration of response. We have, though, one patient will have their second scan as well. That will be 16 weeks. This is still too early. You need to talk about the duration of response. In terms of why this is encouraging, of course, first-line setting chemotherapy response rate is about 30%. We are obviously trying it in a single-arm trial. It is hard to discern the effect of IDMC added to chemotherapy. Based on the discussion with the PR, it seems to be such that you have overall responses. [audio distortion]. Got it. Maybe just switching gears real quick to the manufacturing. Gil, you mentioned Lyon and Princeton. Just given what's been happening in our industry with the number of CRLs being handed out by the FDA, I was wondering if you could talk through, I guess, how prepared you are. If everything works out the way that we all hope in the fourth quarter with the TRYbeCA-1 study, how prepared you are regarding these manufacturing facilities. Do inspections take place prior to filing, or do you have some sort of data or confidence you might be able to give us regarding the preparedness of the manufacturing facility? Thanks. Thank you, Reni. Good question. Basically, you have to make a distinction between Lyon and Princeton. In Lyon, we're doing this since 2009, we've total produced, I think, 5,000 batches. We have been inspected on regular basis. The GMP inspections happen in Lyon every two years. This site consists of 12 clean rooms. With this site, we have done our clinical programs, also we anticipate to be able to do the early commercial. The first year and a half of commercial. Yes, with Lyon, we should be able to handle that. Obviously, as soon as we see the green lights, we will work on an additional site. We anyhow need a backup site also for manufacturing. That will be triggered as soon as we see the positive data in the cards. For ALL on its own, Lyon is large enough. The indication of hypersensitive ALL. It's really the pancreatic data that will trigger the extension manufacture of capacity in France. In Princeton, the site is newer. We inaugurated the site in 2019, and we started producing really in clinical in 2019. The site has done really well. It's a larger site. It's more expansion of facility there. Has not been inspected yet, the FDA inspections happen after filing. We've obviously done mock inspections, and we have already had two interactions with the FDA on CMC topics. Also here, we believe and think that this site indeed can cover the initial commercial activity, probably year and a half. Same thing, it can cover ALL on its own, the full potential of ALL. Based on positive data, pancreatic, the second U.S. site will be in the. We're already preparing the ground for that, sort of anticipating locations, looking for potential sites, but we're not spending money on it yet. We'll wait until the data come out. Great. Thanks for taking the questions. Thank you. Your next question comes from the line of Ingrid Gafanhão from Kempen. Your line is open. Oh, good afternoon. Hi, or good morning. Thank you for taking my questions. I have a pretty brief one. I was wondering for the BLA in ALL, I just wanted to confirm, do you intend this to be under sort of the accelerated approval pathway with the FDA or as the regular approval pathway? Yeah, good question. We have not filed yet for fast track, but we anticipate to do that soon now that things have sort of evolved. Yes, we anticipate that this will be an expedited review of the BLA, meaning roughly eight months of review. Clear. Here you would expect that this would be enough for formal approval, right? You wouldn't expect to have to do any other confirmatory trials after you file or after you get this post-approval. I think this will be the discussion also of the pre-BLA meeting. Where indeed, the base plan is a regular approval. It could be an accelerated approval, as it is called in the U.S., which means that then there is a post-approval commitment for additional work. For the time being, based on the unmet need, based on everything we know so far, the regular approval is the base case. All right. That's clear. Thank you. We have a question from Boris Peaker with Cowen. Your line is open. Hi, this is Cynthia on for Boris. I think a quick one from me. In TRYbeCA-1, what was the final breakdown of patients from the U.S. versus Europe, and how did that impact the choice of chemotherapy? Iman, can you take this? I can. Yes, I can. After the completion of enrollment, we have approximately 40 patients enrolled from the United States. This is still a decent number. What we would like to see is that we have contribution from the U.S. definition. We are comfortable with that. In terms of the breakdown of the chemotherapy, the backbone chemotherapy, it's almost 60/40, 62% gemcitabine approximately, and 40% with the irinotecan-based therapy. Great. Thank you. Okay. Our next question is from Lucy Codrington from Jefferies. Your line is open. Hi there. Sorry. This was just something that I missed in terms of the line quality. You were talking about potentially modifying the expansion cohort for the first-line pancreatic cancer trial. I just wanted to get a bit more detail on that. Thank you. I think what I tried to say is that right now the expansion cohort, which is a typical in a phase I trial, once we achieve the MTD, whether it will be the first three or six patients, then we'll double that numbers. Probably would be up to 18 patients in that expansion cohort. It is not surprising or it's not unusual that as the trial goes on, that the investigator, it is investigator-initiated trial, so it really is up to the investigator whether this would be their continued interest to do expansion cohort, or whether they would like to do maybe a mainly randomized expansion to compare with backbone chemotherapy. I think the point I'm trying to say here is that right now there is an expansion cohort. That's the plan. We don't have a thing. We try to be open-minded in terms if there are any additional feedback interests from the PI to modify that expansion cohort. That could actually give us a better readout. That's I think the point I was trying to make. Right now, there are actually no plans to change. Okay, thank you. Again, as a reminder, if you would like to ask question, press star, then the number 1 on your telephone keypad. That's star one to ask your question. There are no further questions then. I would like to turn the conference over back to Mr. Gil Beyen. Okay. Thank you. Thank you all for your participation and attention, and obviously for your continued support for ERYTECH. Indeed, a key year, and we will, as always, we'll keep you posted on the progress. Further, wish you a great day. Thank you all. This concludes today's conference call. Thank you for joining. You may now disconnect.