Good day and thank you for standing by. Welcome to the ERYTECH Business Update and Financial Highlights for the second quarter of the year 2022 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 one on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Gil Beyen. Please go ahead. Thank you, and good afternoon. Good morning. Bonjour à tous. Thank you for joining us for our business and financial update call to discuss the business highlights year-to-date and the financial for the first six months of this year. We announced our business and financial update yesterday evening, and the press release and 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 2, I'd like to draw your attention to the disclaimer, reminding you that today's call includes forward-looking statements such as related to the company's operations, timelines, and financials, and as you know, they all involve risk and uncertainties that could cause actual timings and results to differ. Switching to slide three, the agenda for the call is quite standard. I will, as usual, start with a short introduction and present the key business highlights of the year to date, focusing on Q2 and events that occurred after our last call in May. After this, Eric will present an update of our key financials and the cash balance, and he will also summarize the strategic priorities and expected milestones for the year to come, before we then open the lines for Q&A. All three of us will be available for your questions afterwards. Now moving to the presentation, a quick company overview of slide four. It's for anyone new to the company and then for completeness. Brief overview of ERYTECH. ERYTECH is, as the name tells it, focused on the development of erythrocyte-based therapies, red blood cell-based therapeutics. We've been in this field since quite a time. We have been working first with a lead product, eryaspase GRASPA, which product we established the proof of concept in leukemia, in pancreatic cancer through different clinical trials. I'll explain more about this. We recently decided not to pursue further development of eryaspase, and this is following a setback, a phase 3 trial that did not achieve its primary endpoint, and also new regulatory hurdles that we encountered for our development in ALL. More about this in a minute. The focus is now really on our preclinical pipeline, which includes work in rare diseases and work also on extracellular vesicles. We call it ERYCEV, erythrocyte-derived extracellular vesicles. It's in the exosome space. Exciting possibilities there. Earlier stage, obviously. The other key element of this is strategic partnering that we have announced since quite a while and where we're making good progress. That, on slide 5, brings me to the key items for the second quarter and year to date. Quite intensive. First of all, obviously there was in April the sale of the Princeton facility. Princeton facility is a state-of-the-art cell therapy facility that we built in 2018, and this was in view of the phase 3 clinical trial with GRASPA in pancreatic cancer. For the trial and for the early commercial. When the trial then did not turn out positive, this facility was clearly too big for our needs. We then launched a sales process and were pleased to find a good partner with Catalent. We sold the facility to Catalent, one of the leading CDMOs in cell and gene therapy, and we sold. The consideration we received was EUR 44.5 million. Also, our entire team, site team, transferred to Catalent. This was in May. That was the first item. The second item is a more difficult one. This was in August, recently, and this is where we had to announce that after a long development path and encouraging data in ALL, hypersensitive ALL, we decided to no longer pursue our path to a US approval. You may remember that we had been encouraged by positive data that we saw end of 2020 in a phase 2 trial run by the NOPHO, which is the pediatric oncology group of the Nordic countries in Europe, that based on this trial, we had a long dialogue with the FDA to explore the path to approval indication based on this IST run in Europe. The dialogue started off very well with a good pre-BLA meeting already more than a year ago. This was in June 2021. After which we had multiple exchanges and data requests with the FDA, including the submission of a pediatric plan. This was in July. Initial pediatric plan, IPSP. And there we received feedback in August. Feedback that asked for additional clinical data. Basically, we had a long evaluation of this feedback, the possibilities, pros and cons. After all, taking into account this need for additional data and the need and the changes in the competitive landscape or new approval in this very small indication, we took the difficult decision to abandon our plans for GRASPA in ALL. Clearly we announced this a few weeks ago, and it's the stop of a long development in a long work with GRASPA in ALL. Another element, the number three here on this list, is that we recently received the feedback or the results from the start of the TRYbeCA-2 trial. I must state that TRYbeCA-2 trial was a phase 2 trial to evaluate ERYTECH's GRASPA in metastatic TNBC, triple negative breast cancer. This was a trial in view of building on the pancreatic trial and in view of broadening out to other solid tumors. Target enrollment 64 patients. We stopped enrollment with that when we saw the disappointing results of the pancreatic phase 3 trial, the TRYbeCA-1 trial. We stopped enrollment end of last year. We had 27 patients enrolled at the time, 11 and 14 respectively, in the respective groups. It was a randomized trial. The trial steering committee met very recently in September and reviewed the results of these patients. Overall conclusion was that the treatment was well-tolerated, but no clinical benefit was demonstrated. It's in fact difficult to draw any conclusions given the immature closure of the trial and the small number of patients. Absent a clear signal, this result reinforced our decision to stop the GRASPA development altogether. For now, obviously, this means quite a change for the company, with the lead product being abandoned. The priorities for the company now is, A, deep restructuring. We have cost reduction and restructuring. We launched it already in early this year. We have performed staff reductions in the U.S. and now have launched a restructuring plan, a social plan in France. This has been launched and now also recently approved by the labor authorities. Eric will provide more detail in terms of what is the financial impact of this cost-saving plan. Second priority, on... After the sort of initial change is clearly to focus on our preclinical programs. We have work ongoing, as I mentioned, in rare diseases, and then specifically the new kid on the block, but in the meantime quite nicely advanced, is a work on our extracellular vesicles. The exosome-like program, the vesicles derived from loaded red cells. It's building on our ERYCAPS technology. We encapsulate drugs in the red cells, and then we do the vesiculation. We have presented first results. This was feasibility in vitro earlier this year, and we are now working on the in vivo work and also further feasibility. This technology holds a lot of promise for what we believe is promising in immuno-oncology applications on the one hand, and potentially also for the delivery of genes of RNA. Non-viral gene delivery, for example. Work to be done still, but at least an interesting and quite an exciting platform to work on. More to come. We'll keep you updated on the results soon. Then the third and the last bullet on this slide is the strategic partnering. We've launched this process already in November last year after the phase three setback in pancreatic cancer. First step has been the sale of the Princeton facility to Catalent. We are now. We obviously continue with this step behind us. We then broadened out, looked at very different pools of strategic options. We have now, after a broad screening of potential options, we've zoomed in on a few valuable, in fact, any lead options. I mentioned it in the press release. We hope to be able to provide an update soon in the fourth Q, as we said. The partnering we're envisaging is really building on what ERYTECH has to offer. We are a listed company. We have, and Eric will explain, solid cash basis. We have a great team left after restructuring. We have a manufacturing facility in Lyon, a cell therapy manufacturing facility, and obviously we have our ERYCAPS and ERYCEV platforms. Along these elements, we are. We have searched for partnering options, and we're now pursuing viable lead options as we speak. With this, I will stop the introduction and hand over to Eric, who will provide an update on our Q2 and first half financials. He will also, at the end, summarize the news flow, after which we'll come back, the three of us, for Q&A. Eric, the floor is yours. Thank you. Thank you, Gil Beyen. Good morning, everyone. Bonjour à tous. We are now reviewing the financial highlights for the first half of this year. We're on slide 7 of the slide deck, and we're starting with P&L information. As Gil Beyen just explained, a number of unusual significant events happened in the first 6 months of this year, from the sale of the US production facility to the restructuring and resizing of the company's operation in France. These transactions obviously impacted our financial results as of June 30. Beyond the one-off impacts of these significant unusual transactions, as we call them, the financial results for the first half of 2022 confirm a steady and notable decrease in operating expenses and cash utilization. That's in connection with the completion and closure of most of our clinical development activities and the related decrease in production activities. With that, net loss for the first half of 2022 was EUR 1 million, which is a EUR 27 million improvement over the same period of last year, and obviously related mostly to the EUR 24.4 million net capital gain on the sale of a production facility in Princeton. Operating expenses of EUR 25.2 million. We're also showing a EUR 6 million decrease, that's minus 19% year-over-year, with a EUR 5.9 million decrease, minus 25% in R&D expenses, again, related to the decrease in clinical development activities. Total operating expenses included an asset impairment provision of EUR 2.5 million on the Lyon production facility related to the end of eryaspase operations, and a EUR 1.9 million provision for restructuring and revising the just mentioned related to the French operations. Income tax included also a provision as of June 30, 2022 of EUR 3.7 million. That's actually $4.1 million, reflecting the best estimate to date of the tax impact of the capital gain from the sale of the Princeton facility. Now moving on to slide 8 for comment on cash. As of June 30, 2022, ERYTECH had cash and cash equivalents of EUR 53.3 million. That's approximately $55.8 million, compared with 33.7 million euro as of December 31 last year. This is a EUR 19.6 million increase in cash position during the first half of 2022, and that was the result of the net cash inflow of EUR 37.16 million received from the sale of the Princeton facility, a EUR 20.4 million of net cash utilization in operating and investing activities, obviously including the sale of the Princeton facility, and a EUR 2 million of net cash generated in financing activities, including a EUR 3 million pre-funding of the expected 2021 R&D tax credit. In the period, the variation of the US dollar against the euro led to a EUR 0.4 million positive currency exchange impact. I wish to remind that ERYTECH has not drawn any tranche on the convertible loan facility, the so-called OCABSA, since last year, 2021, and there are no outstanding and unconverted notes. The OCABSA financing line had expired in June 2022. Already this year, the company initiated, Gilles mentioned that already, a deep restructuring and cost reduction program, which is now further intensified with the halt of the BLA process. Considering these ongoing initiatives to reduce operating expenses, the company believes that its current cash position can fund its current programs and plans operating expenses to mid-2024. Now, before we move on to Q&A, a very quick summary of our key strategic priorities and upcoming milestones in the next six months, and that's slide number 9 of the presentation. We're mentioning the still ongoing rESPECT study. This is an investigator-sponsored trial, phase 1 trial in first-line pancreatic cancer, with results expected by the end of this year. Again, the company has no further plan at this stage to continue developments with eryaspase in this indication. The main expected milestone for the rest of the year will be the update on the ongoing strategic review and partnering process. The sale of the Princeton facility was already a first step in that process. That gave us the means and latitude for a strategic refoundation of the company. As Gil explained already, we are in this process of evaluating various strategic options, and we expect, we hope, to give further updates on these strategic initiatives in the fourth quarter of this year. With that, I would like to thank you already very much for your attention, and we will now open the call for Q&A. Gil Beyen, Iman El-Hariry, and myself will be happy to answer any questions you may have. Operator Michelle, it's over to you. As a reminder, to ask a question, you will need to press star one one on your telephone. Please stand by while we compile the Q&A roster. At this time, I am not showing any. Well, excuse me one moment. Please stand by for our first question. Our first question comes from Jacob Mekhael with Kempen. Your line is now open. Hi there, and thanks for taking my question. I just had one and maybe if you could just, you know, elaborate on what kind of partnerships you're looking at the moment, and just give a bit more color on that. Yes. Hi, Jacob. Jacob, Gil here. Basically, yes, we have to face the reality that we don't have a lead program anymore, so we still have the early-stage programs. The real sort of the focus of our partnering is really sort of trying to leverage our listings, our cash, our preclinical programs, and obviously the team that has done a great development, even if the results were not what we hoped. What this brings us to is merger/reverse merger type of options. Clearly we can add something to another company and what obviously we don't have is a lead program. Basically a synergistic way of bringing companies in the space together. Also our facility. You saw that our facility in Princeton had a lot of value. Our facility in Lyon was smaller, but still also for a cell or a gene therapy company clearly can bring us significant value. Does that answer your question? It did that. Thank you very much. Okay. Thank you. At this time, I am not showing any other calls in queue. I would now like to turn the conference back to Gil Beyen for closing remarks. Thank you, Michelle. Just want to thank everyone participating in this call for your attention, for your question, for your continued support of ERYTECH, and wish you a great rest of the day and look forward to speaking again at the next occasion. Our next call, probably. Thanks a lot and have a great day. This concludes today's conference call. Thank you for participating. You may now disconnect.
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