ERYTECH Pharma S.A. (NASDAQ:ERYP) Q2 2019 Earnings Conference Call Transcript

Sep 18, 2019 • 08:29 am ET

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ERYTECH Pharma S.A. (NASDAQ:ERYP) Q2 2019 Earnings Conference Call Transcript

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Presentation
Executive
Gil Beyen

trial and the NOPHO is the sponsor.

And in the preclinical program you see our next product candidate methionase. You see ery- new now and that's a new -- a SQZ label added. So we have partnered our immunoncology and immune modulation activities with SQZ Biotech in Boston. And then, we are continuing to do work on -- preclinical work on metabolic diseases, mainly on -- most advanced on the arginase-1-deficiency.

Moving to the highlights; slide 6, you see here the summary. I will not go in full detail because I have a page for each of them zooming in on these key highlights for the quarter and the year-to-date. Let's go to the first one. It's on Slide 7.

It's obviously our top priority, the Phase III in pancreatic cancer. So, we launched this study in September 2018. It's just a Phase III -- pivotal Phase III study in Europe and in US, about 500 patients to enroll, comparing standard of care chemotherapy to standard of care chemotherapy with eryaspase added, our product, overall survival end point. So we already at the last call, I think we had all 11 countries accepting our clinical trial, so giving our clinical trial authorizations and we are now -- and these many countries are now enrolling really well. So the enrolment is on track or even slightly ahead of track in Europe.

And the news of the quarter is indeed that we now also have the IND accepted by the FDA. So that gives us the authorization to proceed in the United States. We expect that the enrolment in the United States will happen soon, most likely Q4 -- the beginning of Q4.

Next to second line metastatic pancreatic cancer, we are also preparing a smaller still a Phase I study, an IST -- so it's not us who are preparing, but the site is preparing to get started on an IST in first line pancreatic cancer. It's a Phase I in combination with FOLFIRINOX because FOLFIRINOX is gaining a lot of ground in frontline pancreatic cancer. So it -- as soon as we can start producing in Princeton, we will also -- the IND will be filed for this Phase I study. So that's pancreatic cancer.

The next indication for us in solid tumors is triple-negative breast cancer, if you remember, chosen also because of the unmet medical need, but maybe also for this fact that these are metabolically very active tumor types and we expect them also to very dependent on asparagine. It's a proof-of-concept study here. It's a Phase II proof-of-concept only in Europe, about 65 patients to be treated, similar design; standard chemotherapy with or without the eryaspase product with an objective response rate primary endpoint.

So we have clinical trial authorizations in, currently, the four countries in Europe in which the study runs and we have -- something missing in the slides, we have close to 20 sites initiated, not close to two. And patient enrollment has