ERYTECH Pharma S.A.
Q1 2021 Earnings Call Transcript

Published: 8 May 2021

[Gil Beyen:]

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. The press release and the Q1 earnings presentation can be found on the Investor Relations page of our website. And joining me on this call today from 3 different locations are Dr. Iman El-Hariry, our Chief Medical Officer; and Eric Soyer, our Chief Financial and Chief Operating Officer. We are on 3 different locations, and there's some technical issues, but I hope that we all -- that Iman can join us in the meantime. In the meantime, before starting the update, draw your attention to Slide 2 to remind you that today's call includes forward-looking statements such as relating to the company's operations, time lines and financials. And as you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially. Then switching to Slide 3, the agenda. So as usual, I will start with a short introduction and indicating the key business highlights for the quarter.

[Iman El-Hariry:]

I'm here. Can you hear me okay?

[Gil Beyen:]

Yes.

[Iman El-Hariry:]

Okay. Fantastic. Thank you. Good morning, good afternoon, everyone. So really quickly on the highlights from the clinical program and just to add a little bit of color to what Gil kind of detailed. So starting with TRYbeCA-1, and as a reminder, this is our Phase III trial or a trial in second-line pancreatic cancer, led by 2 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 500 patients above with a chronic status in a second-line setting and will be randomized to receive chemotherapy with/without eryaspase. The chemotherapy will span in this 2. Either irinotecan with chemotherapy, the generic irinotecan, or Onivyde plus 5-FU/leucovorin; or the second choice with a gemcitabine/Abraxene. We had the primary endpoint of overall survival and the second endpoints included actually progression-free survival, objectives response, disease control rate. We are also looking for quality of life. And we have been connecting to include as well as tissue materials for plan for extensive biomarker and translational research after the study is reported, especially with the global trial in Europe as well as in the United States. So moving to Slide #9. As Gil mentioned, we enrolled 512 patients end of last year. We had 4 IDMC meetings, and the fourth one, which was conducted in February of this year, where the IDMC recommended that we continue the study without modification. As a reminder, that interim analysis is interim analysis for superiority only. We don't . At this stage, the team, our operational team, in conjunction with the CRO are working literally round the clock to . We have to review. So all of this operational work is currently ongoing to be able to report the study as planned in the fourth quarter of this year. Staying with pancreatic cancer and moving to Slide number 10. This is the initiated trial from , made by in Georgetown. So 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 kilogram of in combination with .

[Eric Soyer:]

Thank you. Thank you, Iman. Good morning, everyone. . So we're now reviewing the financial highlights for the first quarter of this year on Slide #14 of the slide deck, and we're starting with the P&L information. The net loss for the first quarter of 2021 was EUR 11.9 million. We show the decrease in net loss of EUR 5.6 million, it's minus 32% year-over-year; with a EUR 5.8 million decrease, minus 31% in operating loss; and 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, and that was concurrent with the end of patient enrollment in the company's Phase III clinical trial in pancreatic cancer. Also, a EUR 0.3 million decrease in G&A and 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're now moving to Slide 15 for comments on cash.

[Operator:]

Your first question comes from the line of Ren Benjamin from JMP Securities.

[Reni Benjamin:]

I might have missed this in Iman's comments, and so I apologize if you guys have to repeat it. But what was the initial clinical activity that was observed in the IST frontline study? And is there any way to kind of tell why that response might be more or less due to the addition of eryaspase versus not?

[Gil Beyen:]

Ren, I'll start. Iman, you go. Okay, go ahead. Your line is.

[Iman El-Hariry:]

I can hear you.

[Gil Beyen:]

Maybe Iman, I'll -- sorry, Iman, maybe I'll start because your line is really weak, and then you can add if I forget something. So basically, Ren, the initial clinical activity was 2 partial responses -- nice partial responses and a stable disease. So 100% disease control, which it's only 3 patients, obviously, but still, it's encouraging. It's pancreatic cancer, and so that was really the message. And maybe Iman, you want to add to this?

[Iman El-Hariry:]

Yes. Can you hear me?

[Reni Benjamin:]

Yes. It's a really tough connection.

[Gil Beyen:]

No, really not well. No.

[Reni Benjamin:]

Yes. What about duration, Gil? So that is pretty promising, but anything regarding the duration of these partial responses?

[Gil Beyen:]

This was the partial response, obviously, soon after the treatment. So it's the first. So I don't think there is much view on duration yet. Iman, is there a view on duration of these partial responses?

[Iman El-Hariry:]

Not yet. We have -- so the initial assessment was after the first dose of eryaspase. So at least, the minimum we have different views. But we don't have -- the duration will continue until you have the disease progression. So at that, we have the steering committee, we don't have really the full details around the duration of eryaspase. We have, though, one patient who have the second as well. So that would be . to talk about the generation of response. In terms of why this is encouraging? Of course, first-line setting chemotherapy response rate is about 30%. We are absolutely trying in a single-arm trial. It is hard to discern the effect of trials added to chemotherapy. But with that discussion -- based on that discussion recently, this seems to be in terms of that you have which is responding to treatment.

[Reni Benjamin:]

Got it. And then maybe just switching gears real quick to the manufacturing. Gil, you mentioned Leon and Princeton. And just kind of 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 kind of 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? Have inspections -- 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?

[Gil Beyen:]

Yes. Thank you, Ren. Good question. So basically, we have to make a distinction between Leon and Princeton. In Leon, we're doing this since 2009, so we have totally produced, I think, 5,000 batches and we have been inspected on a regular basis. So GMP inspections happen in -- every 2 years. This site is -- consist of 12 clean rooms. And so with this site, we have done our clinical programs, but also we anticipate to be able to do the early commercial, so the first year, 1.5 years of commercial. So yes, with Leon, 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. So that will be triggered as soon as we see the positive data in the cards. For ALL on its own, Leon is large enough. So the indication of hypersensitive ALL, so it's really the pancreatic data that will trigger the extension manufacture of capacity in France. In Princeton, the site is newer. We started only -- we initiated or inaugurated the site in 2019, and we started producing, really, in clinical in '19. But the site has done really well. It's a larger site. It's more expansion of facility there. Has not been inspected yet. So the FDA inspections happen after filing, but we've obviously done mock inspections, and we have already had 2 interactions with the FDA on CMC topics. So also here, we believe and think that this site, indeed, can cover the initial commercial activity, probably 1.5 years. And same thing, it can cover ALL on its own fully, 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.

[Operator:]

Your next question comes from the line of Ingrid Gafanhao from Kempen.

[Ingrid Gafanhao:]

I have a pretty brief one. So I was wondering for the BLA in ALL, I just wanted to confirm, is this going to be -- do you intend it to be under sort of the accelerated approval pathway with the FDA? Or as the regular approval pathway?

[Gil Beyen:]

Yes. Good question. We have not filed yet for fast track, but we anticipate to do that. It's soon now that things have sort of evolved. And so yes, we anticipate that this will be an expedited review of the BLA, meaning roughly 8 months of review.

[Ingrid Gafanhao:]

Clear. And Gil, then, you would expect this would be enough for more approval, right? You wouldn't expect to have to do any other confirmatory trials after you file or after you get this post approval?

[Gil Beyen:]

I think this will be the discussion also of the pre-BLA meeting. So we're, indeed -- the base plan is a regular approval. It could be an accelerated approval, as it's called in the U.S., which means that then there is a post-approval commitment for additional work. But for the time being, based on the unmet need based on everything we know so far, the regular approval is the base case.

[Operator:]

We have a question from Boris Peaker with Colin.

[Shau-Wei Chen:]

This is Cynthia on for Boris. I think a quick one for me. In TRYbeCA-1, what was the final breakdown of patients from the U.S. versus Europe? And how does that impact the choice of chemotherapy?

[Gil Beyen:]

Iman, can you take this?

[Iman El-Hariry:]

Okay. I can. So in -- for the after the conclusion of enrollment, we have about approximately 40 patients enrolled from the United States. This is still a decent number. I mean what is -- if you would like to see is that we have contribution from a U.S. population, so we are we are comfortable with that. In terms of the breakdown of the chemotherapy, the backbone chemotherapy, it's almost 60-40, 60% Abraxane and 40% irinotecan-based therapy.

[Operator:]

Our next question is from Lucy Codrington from Jefferies.

[Lucy Codrington:]

Sorry. Again, this was just something that I missed in terms of the line quality. Just -- 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.

[Iman El-Hariry:]

Okay. 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 that NTD, with the first 3 or 6 patients, then we'll double that number. Would -- probably would be up to 18 patients in that expansion cohort. It is not surprising, it is not unusual that as the trial goes on that the investigator -- it is an investigator-initiated trial, so it really is up to the investigator whether this would be their continued interest to do expansion cohorts or whether they would like to do maybe many or randomized expansion to compare with backbone chemotherapy. So I think that what I'm trying to say here is that right now, it is an expansion cohort, that's the plan. But we don't have -- I think thanks to the open-minded in terms of there are any additional feedback interest from the PI to modify that expansion cohort. That could actually give us a better readout. So that's, I think, the point I was trying to make. But right now, there are no -- actually, no plans to change.

[Operator:]

There are no further question at this time. I would like to turn the conference over back to Mr. Gil Beyen.

[Gil Beyen:]

Okay. Thank you. Thank you all for your participation and attention and for -- obviously, for your continued support for ERYTECH. It is 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.