Good morning, and thank you for standing by. Welcome to the ERYTECH Business Update and Financial Highlights for the third quarter of 2022. At this time, all participants are in 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 one on your telephone. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Gil Beyen, CEO of ERYTECH. Please go ahead. Thank you. Good afternoon, good morning. [Foreign language] Bonjour a tous. Thank you for joining us for our business and financial update call to discuss the business highlights for the third quarter of 2022 and the financials for the first nine months of this year. We announced our business and financial update yesterday evening, and the press release and webcast presentation can be found on the Investor Relations page of our website. Turning to Slide 2, before starting, as you know, I have to draw your attention to the disclaimer to remind you that today's call includes forward-looking statements. As you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially. Slide 3, the agenda. 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. I will start with a short introduction and 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 September. After which, Eric will present an update on our key financials and cash balance. He will also summarize the expected milestones before we open up the lines for Q&A, at which all three of us will be present. Slide 4, and this is really an update or an overview for anyone new to the company. I think most of you know, but for completeness. Who is ERYTECH? ERYTECH, the name says it focused on the development of red blood cell-based therapeutics. We have been active in this field for quite some time, focused, and developed the proof of concept with a product eryaspase, which is asparaginase encapsulated in red blood cells, and for which we have had encouraging preclinical results in ALL, acute lymphoblastic leukemia and pancreatic cancer. As this will be a point on the next slide, we have recently decided not to pursue further development with this product. Focus is now on our pre-clinical programs. We're still working on the encapsulation, the ERYCAPS platform, but now working with vesicles derived from these, from the loaded red blood cells. Also, pre-clinical programs in rare diseases. The other priority clearly is pursuing partnering options, more in a minute. Quickly to Slide 5, the business highlights, the main news items of the third quarter and year-to-date. The first one was already largely presented at our last call. It is the fact that indeed in August, we decided to no longer pursue our activities to try and obtain a U.S. approval for GRASPA in a subsegment of ALL, in hypersensitive ALL. This was based on feedback we just had then received from the FDA, from which it became clear that we needed additional clinical data, which in the competitive environment and the whole context of this specific sub-indication was an impossible task for us. Another one also presented in September was that there was a steering committee in the TRYbeCA-2, phase II trial in Triple-Negative Breast Cancer, which saw good safety but no efficacy signal. It was a small number of patients because we stopped this trial prematurely, but still there was not a sort of a signal based on which we said we should continue this activity. The results of this combined then with the earlier setback in the pancreatic cancer phase three trial, that was at the end of last year, all that together led us to the decision to stop the GRASPA or eryaspase's development altogether. The priorities of the company now, obviously, first of all, a deep cost restructuring, cost reduction and restructuring. We've launched this already, as soon as we had the news, but mainly after the sale of the, the Princeton facility. We have performed staff reductions in the U.S. and have also implemented now a restructuring plan, a plan social, it's called in France, which is now fully implemented. Still at the end of the implementation, but compared to the number of people at the time we announced the pancreatic phase III trial, which is end of last year, we are now at roughly 75% less than at that time. So small. A steep reduction of the team size. The second priority for the company and of the remaining 45-ish, 40, 45 people, we have kept a core team in our R&D programs. Focusing on the second priority, our pre-clinical activities, especially on the vesicles, the extracellular vesicles. It's the exosome-like, but now derived from red cells where we see a lot of promise for immuno-oncology applications and potentially also for RNA and or other non-viral gene delivery. We have over the past months shown in vitro feasibility. The in vivo work is ongoing. We expect to be able to provide an update in the beginning or in the first quarter of next year. We're also working on rare disease programs that we already had in fact, rare disease programs while we were working on GRASPA. They did not get much attention, so we're now re-reviving, giving them renewed attention. Also here, expect to be able to provide updates in the first quarter of next year. The third and main priority of the company is, we've announced it already after the phase III trial results, is the search for strategic options. We realize that ERYTECH still has a lot to offer, but doesn't have a lead program anymore. The sale of our U.S. production facility, the Princeton facility to Catalent was a first step, and we are now working on different options. We did a broad screening. We've zoomed in on a few valuable options and hope to be able to provide an update before the end of the year or at least in the coming months. What we're trying to do here is indeed capitalize on ERYTECH being a listed company with cash. Eric will provide an update. With still a GMP facility, with technology, IT and a core team, a research core team, also a corporate infrastructure that can support such a company in a combination. That's it for the slide five, for the highlights. I will stop here and hand over to Eric, who will provide an update on the financials for the first nine months, and we'll summarize the news flow afterwards. Eric, all yours. Thank you. Thank you, Gil. Good morning, everyone. [Foreign language] Bonjour a tous. We're now reviewing the financial highlights for the nine-month period that ended on September 30. We're on Slide 7 of the slide deck. We're starting, as usual, with P&L information. As already noted in our previous call for Q2 results, the financial results for the first nine months of 2022 confirm a significant and accelerated decrease in operating expenses and cash utilization in connection with the completion and closure of most of our clinical development activities, and also the deep restructuring of the company. As a result, the net loss for the first nine months of 2022 was EUR 6.2 million, which was a EUR 35.4 million improvement over the same period of last year, reflecting the EUR 24.4 million net gain on the sale of the Princeton facility and the sharp decrease in operating expenses that show an accelerated decrease of EUR 15.5 million, that's - 33% year-over-year. It was - 19% at the end of June. The cost reduction was mostly on R&D, with a EUR 14.4 million decrease in expenses related to the gradual termination of clinical programs, while G&A expenses also showed a EUR 1.4 million decrease over last year. Total operating expenses of EUR 31.2 million included an impairment provision of EUR 2.5 million, mainly on the Lyon production facility and relating to the end of the eryaspase operations, as well as a EUR 1.9 million provision for restructuring related to the staff reduction plan in France. Income tax included in 2022 a provision of EUR 3.8 million, still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis. We're now moving on to slide number eight for comments on cash. At the end of September this year, ERYTECH had cash and cash equivalents totaling EUR 47.3 million or approximately $46.3 million, compared with EUR 33.7 million at the start of the year. The EUR 13.6 million net increase in cash position during the first nine months of 2022 was the result of the net cash of EUR 37.6 million received from the sale of the Princeton facility. A EUR 27.4 million cash utilization in operating and investing activities, of course, excluding the sale of the Princeton facility, and a EUR 1.6 million generated in net financing activities, and that was including the EUR 3 million pre-funding of the expected 2021 R&D tax credits. Finally, in the period, the variation of the U.S. dollar against the euro led to a EUR 1.7 million positive currency exchange impact. As already mentioned, the company has initiated earlier this year a deep restructuring and cost reduction program. These cost reductions have been further intensified with the help of the GRASPA program and BLA process. Considering these ongoing cost reductions, the company believes that its current cash position can fund its current programs and plans operating expenses to mid-2024. This is of course sort of a theoretical runway as we will obviously not sit on this cash for 20 + months. Our plan is, Gil has mentioned that, to restart the company on a new development pipeline with a strategic partner, in which case the current projections as is will not be relevant anymore. Before we move on to Q&A, a quick wrap-up of our key news flow and milestones expecting over the next six months. This is slide number nine of the presentation, which are reflecting of course our key current priorities. Starting on one end, with the focus on the ongoing preclinical programs and more particularly our program with red blood cell ex-derived extracellular vesicles. We call this novel technology ERY-C-E-V or ERYCEV. We expect to report on our preclinical results in a few months. Of course on the other end, an update on our partnering process. We're still evaluating a number of strategic options to best leverage the company's assets and capabilities in a business combination with a strategic partner. Valuable options are under discussion and we expect to give further updates on this hopefully before the end of the 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, Iman, myself will be happy to answer any question you may have. Operator Catherine, over to you. Thank you. As a reminder, to ask a question you'll need to press star one one on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Boris Peaker with Cowen. Your line is open. Oh, great. Thanks for taking my question, good morning or good afternoon, depending where you are. I just have one simple question and that is, are there any clinical data readouts specifically that we should be expecting, particularly maybe from the, your new ERY-ASP program? I don't know, over the next six-12 months, will we see any visibility into that clinically into this program? Hi, Boris. Good morning. Gil here. No, on the ERY-ASP or the preclinical programs, nothing to expect in the next six - 12 months. They're preclinical still and still some work to IND. The preclinical out-readout still is the ongoing rESPECT trial. It's a phase one trial in first-line pancreatic cancer, an IST run by Georgetown University, where the trial is still treating patients. We heard from the PI that he wants to present this data at ASCO. It's sort of, what is it? June, nine months away. Got it. Thank you very much for taking my question. Thank you, Boris. Thank you. There are no other questions in the queue. I'd like to turn the call back to Gil Beyen for closing remarks. No questions. Want to thank everyone for your participation, your attention and your continued support of ERYTECH. As always, we will keep you posted on progress and, yeah, wish you a nice rest of the day. Yeah, speak soon, at least at the next call in a couple of months. Have a good day. This concludes today's conference call. Thank you for participating. You may now disconnect.
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