Good day, and thank you for standing by. Welcome to Erytech Business Update and Financial Highlights for the first quarter of 2022 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll 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 Gil Beyen, Chief Executive Officer. Mr. Beyen, please go ahead. Thank you, Norma. Good afternoon, good morning. Bonjour à tous. 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. Joining me on the call today are Dr. Iman El-Hariry, our Chief Medical Officer, and Eric Soyer, our Chief Financial and Chief Operating Officer. 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. 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 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, the ones 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 available for Q&A. Moving on to slide four, and this is really for anyone new to the company and for completeness, a brief overview, so you know that Erytech is focused on the development of red blood cell-based cancer therapeutics with the lead product, Graspa. Graspa or eryaspase, which is asparaginase loaded in red cells, targeting the cancer cells' altered asparagine 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. In parallel, we have a phase 1 ongoing in first-line pancreatic and a phase 2 in triple-negative breast cancer. Iman will provide an update shortly then. 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 Catalent at our former manufacturing facility in Princeton, New Jersey, for supply to the U.S., North America, I should say. That's all indeed the highlight of the quarter or the year to date. Slide five. You saw probably the announcement. It was on April 25, the sale of our Princeton facility to Catalent. We sold the site for a consideration of EUR 44.5 million. In the meantime, already our entire team, 40 people in total, transferred to Catalent and are working at the site for Catalent, and also for us, because we entered in a long-term supply agreement with Catalent for the manufacturing and the supply of our lead product. On the one hand, it was with pain in heart to see our beautiful site and our great team go to Catalent. 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, 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. 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. I want to take the occasion to thank our team for great efforts and contributions to Erytech. They made this site a real landmark site, and that is also what Catalent saw. Obviously, we wish them all the best for their new future in their new context. Clearly we'll remain in close contact as they will continue to produce our Graspa 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 EUR 55 million, approximately $60 million, although the dollar is changing rapidly these days. Which, so and Eric explained more, but indeed it has, in combination with the reduction of the cost basis, extended our cash horizon until approximately mid-2024, so a bit more than two years. Then the next question, obviously, then slide five. The question is clearly, what will we do with this money? The answer is relatively simple. We will continue to focus on the key priorities we are working on. The first one, obviously, is our attempt to get the BLA submitted for Graspa, to get the approval for Graspa in hypersensitive ALL patients, in the US first. Iman 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. 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 preclinical opportunities, because our ERYCAPS® technology is very versatile. Many types of molecules can be encapsulated, many ways to use the red cells. A new program that we're increasingly enthusiastic about, we recently presented results at the conference on the European Red Cell Society, it was in Italy, is to use the encapsulated red cells to develop extracellular vesicles, exosome-like. 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 Erytech. Then the third priority is to continue the search for strategic options for Erytech to complete the story. The Catalent deal, you followed it. After the phase three results in pancreatic cancer, we retained a specialized advisor, Torreya, to help us in looking for the strategic options for the company. Catalent 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, extending the pipeline 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. I will stop here and hand over to Iman, 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. Iman, the floor is yours. Thank you, Jean. Good morning, good afternoon, bonjour à tous. I have a few slides to give regarding the clinical update. I will start with slide number eight, and here the focus is, on the key project, the Acute Lymphoblastic Leukemia. Here I'm gonna provide a quick update in terms of our progress towards the filing for approval in the hypersensitive patients. As you know, we have a study which was investigator-initiated trial, an IST study, which was reported back in during ASH 2020, where eryaspase or Graspa was given in patients who have developed hypersensitivity reactions to prior asparaginase therapy. In that study, there was a sustained prolongation of asparaginase activity, and patients were able to receive the intended courses of treatment. With that, we actually made the decision to move forward in seeking an approval for this indication in patients with hypersensitivity. It's important to know that there is already an approved product in the United States, Rylaze, which was approved mid of last year. Moving to next slide, number 9, where we are today on the BLA front. We'll continue to have the discussion and the dialogue with the agency and really since mid-2020. You may recall that we have also our pre-BLA meeting last June, and where we received. It was a very collegial meeting and we had a very constructive feedback on our plan and the structure for the BLA this year. Following that pre-BLA meeting, we were granted Fast Track designation, which we continue to increasingly like because it enables our continuous interaction and dialogue with the agency. Where we are today, it's still an ongoing discussion with the agency. They are continuing to review information as they request on an ongoing basis. Recently a particular part of the submission, as you may know, which is also similar in Europe, is we have to have a pediatric plan or pediatric waiver. This pediatric plan is currently in review. We have received the initial feedback from the agency, and so we will be providing our revised application for the pediatric to be reviewed by the pediatric committee at the FDA front. With that, once we have a green light from the agency, we will move towards our BLA submission. We'd like to take more of a staggered approach, and so we file first in United States, and then we go back to Europe and start looking for the potential for also filing and seeking similar indication. Moving to slide number 10. I'll switch gears to other clinical programs, and I will start with TRYbeCA-1, which as you know is our pivotal trial in second-line pancreatic cancer. We have presented the key highlights from the study a few months ago at ASCO GI. In that study, we have also seen an interesting signal in a subgroup of patients based on a pre-planned analysis. We continue to assess the data and work with our CROs to see, you know, what merits further investigation in that disease. The RESPECT trial, which is the investigator-initiated trial led by Georgetown, continues to enroll patients, and we are really on target to expect results from the center around the second half of this year. Last but not least, the update on TRYBECA-2. 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. Given the TRYBECA-1 results, we completed this study, and so we completed the enrollment at phase 2/4, almost close to what we would have expected for an interim analysis, so it's close to 30 patients in total. Again, we are expecting the results during the Q3 of this year, as we are currently doing a lot of data cleaning to be able to report the results of the study. 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. Eric, it's over to you. Thanks a lot, Iman. Thank you. Good morning, everyone. Bonjour à tous. 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 P&L information. You can see that net loss for the first quarter of 2022 was EUR 11.9 million, and it was stable year-over-year with a 0.7 million improvement. It was -5.5% in operating loss and a 0.7 million decline in net financial income. The 0.7 million improvement in operating loss was attributable to the 2.4 million decrease in pre-clinical and clinical development expenses. That was offset in part by the EUR 0.9 million decrease in other income from R&D tax credits, but both reflecting the decrease in the company's clinical development activities. In the same time, G&A expenses increased by EUR 0.8 million, and that was mostly related to legal and due diligence expenses for partnering activities. We're now moving to the next slide number 13, for comments on cash. As of March 31 this year, Erytech had cash and cash equivalents totaling EUR 25.1 million, and that was approximately $27.9 million, compared with EUR 33.7 million as of December last year. The EUR 8.6 million decrease in cash position during the first three months of this year, with the results of a EUR 10.7 million net cash utilization in operating and investing activities and a EUR 1.8 million generated in financing activities, and that included a EUR 2.3 million prepayment of a portion of the expected 2021 R&D tax credits. In the same time, the variation of US dollars against the euro led to a EUR 0.3 million positive currency exchange impact. Please note that the company, in that period, but also, since a long ago, has not drawn any new tranche on the convertible note facility, actually since August 2021. As of September 2021, there were no outstanding and unconverted notes. Hence, the company does not plan to draw any further or OCABSA convertible notes tranche until the expiration of the financing facility next month. As already mentioned by Gil, the sale of the Princeton facility for $44.5 million, approximately EUR 40 million to EUR 41 million, depending on the exchange rate, has brought Erytech's cash and cash equivalents to approximately EUR 55 million, which is about $60 million, at closing of the transaction on April 22. 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 related to running costs of the Princeton facility, we believe that the company's current cash position can fund its current development programs and planned operating expenses to mid-2024. Now 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 key milestones over the next 12 months. Already stated by Gil and Iman, the submission of our BLA dossier for eryaspase 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. We also have two ongoing trials, and our teams and the trial investigators are working on presenting data to date, starting with the phase two trial of eryaspase in TNBC. The trial's name is TRYBECA-2, where we expect to report data in the third quarter of this year. The phase I IST trial in the first-line pancreatic cancer. The trial's name is RESPECT, with results also expected in the third quarter of this year. Of course, not least, the ongoing strategic review and partnering process. The sale of the Princeton facility to Catalent was already a first step in that process, and that gives us the means now to pursue the Graspa BLA, complete the ongoing trials, and pursue the most attractive pre-clinical programs. We're now looking at options for the further development and commercialization of eryaspase and for ways to leverage our 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. Operator Norma, over to you. Thank you. As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Boris Peaker with Cowen. Your line is now open. Good morning, and 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? Hi, Boris. I'll take this question. Thanks. Thanks for it. Hypersensitive ALL, it's the patients who develop indeed hypersensitive to the. In the U.S., it's the pegylated asparaginase, which is the Oncaspar or the Asparlas. It's roughly, numbers vary, but around 20% of the patients who will develop these hypersensitivities, leading to about 1,000 patients in the U.S. every year with these forms of hypersensitivity, and which includes sort of silent deactivation. Got it. What do you think kind of a reasonable pricing is in those patients? The price levels for Rylaze are high. Rylaze is a drug that needs 12-14 injections per month, up to 5 vials, each vial in the order of $4,000. You see price ranges from between sort of a little bit below $100,000 and up to above $200,000 per month. That's, it's one of the more expensive oncology drugs. The advantage with eryaspase has, it's only every other day. In fact, Rylaze now has Monday, Wednesday, Friday injections, so it's 12 times per month. But we can have 2 times per month. It's every other week dosing with eryaspase. Got it. My second question on TRYBECA-2. What do you need to see in that study to continue with triple-negative breast cancer? I leave this question to Iman. Boris, can you repeat? I didn't hear the first part on the TRYBECA-2. Yeah. Just about the TRYBECA-2, 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 of concept trial, the primary endpoint is disease control rate, and then we have a key secondary endpoint, which is objective response as well as progression-free survival. 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% or 25% difference from the control arm to see that there is an interesting signal of activity to take further into a larger trial. Got it. Thank you for taking my questions. Thank you. Our next question comes from Jacob Mekhael with Kempen. Your line is open. Hi there, 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? Thank you, Jacob. I'll, I think Iman is best placed to answer these questions also. Okay. Thank you. Thank you, Jacob. When we had actually the continuous discussions, they you know it's and on a clinical front, as well as there are. In fact, in each module, for example, on the CMC, there were a lot of information that they requested, which they are still under review. We get, like, every few weeks, we get a response on this is an accepted proposal, et cetera. 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 the rationale. We've been waiting for some of the feedback and so forth. These are the things that when we provided our instruction for the dossier, they subsequently asked some questions and information that they wanted to review prior to the actual BLA 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 waiver. Since this indication is also including pediatric patients, we are not seeking a pediatric waiver. We provided information on how we would address the whole thing around the pediatric plan. These are again additional responses to the questions from the agency. We are working on this. The next meeting, for instance, for the pediatric committee is in July, which they will review our revised application. You can see it's a very iterative process more or less. We get question, we respond, we may get additional questions or the issue or the topic is closed and we move to the next step. It is actually, by the way, very helpful because hopefully when we reach the BLA phase, we know what the agency is requiring further CMC and so that iterative process is also helping us to continue improving our overall decisions of how to address these specific topics, et cetera. Okay, I see. Thank you. I also have another question. Besides larger indications that require a lot of money to pursue, are there any smaller ones or POC indications that you could consider investigating with eryaspase? I will take that question. Yeah, sure. Gil can add. No, no, go ahead. The short answer is yes. The long answer is that there are a few activities that we are doing. For instance, we would like to see the completion and the report of RESPECT-2, as well as, you know, our ongoing further interrogation of the TRYBECA-1 result. First, to see whether or not we should continue investigating Graspa in pancreatic cancer. Of course, that TRYBECA-2 will also inform the decision. More globally or more broadly, this is a drug that targets metabolic, at least one of the metabolic pathways in cancer. Therefore, we have not utilized the full potential of this drug in other tumor types. you know, 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 informed insight and decision which indication to go further with, to assist Graspa. The story is not yet finalized and is not yet over with this drug. Gil? No, I think that's a good answer, Iman. Maybe just to add, I think if you ask for smaller indications, but still whereas the cancer metabolism, the asparagine glutamine metabolism is known to play a role, is for example, NK/T-cell lymphoma. So obviously pending further progress with the ALL, but that clearly could be an indication to take a next step. In hemo. Iman mentioned the solid tumor indications, but hemo also we see opportunities. Mm-hmm. Nice. Thank you. I have one more, if that's okay. Sure. Expand on what would be some of the applications of the red blood cell vesiculation technology that you would consider pursuing yourself, or is this something that you're considering to make fully available for partnering? It's a real good question. Obviously, it's still early for us. For example, we have seen interesting application already in immune oncology, like for example, encapsulating STING agonist, then vesiculating and really seeing very good uptake by the macrophages and, obviously still work to be done there. That could be depending on how we progress, something we continue to do internally or partner. Another application we see clearly an increasing interest and also excitement is if the red cells could be a very good, the vesicles of red cells could be a very good vehicle to, for example, deliver RNA. If we encapsulate RNA in the red cells and then vesiculate, this could be a way, for example, for RNA delivery ex vivo or in vivo, sorry, 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. Okay. Thank you very much for those answers. Okay. I'm showing no further questions at this time. I'd like to hand the conference back over to Mr. Gil Beyen for closing remarks. Great. Thank you, Norma. Just want to thank everyone for your participation, your interest, your attention today, and for your continued support of Erytech. I wish you a great rest of the day, and I look forward to speaking again at the next occasion. Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.
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