Q3 2022 Erytech Pharma SA Earnings Call

November 22, 2022

The conference will begin shortly. To raise your hand during Q&A, you can dial star 11.

Operator: The conference will begin shortly. To raise your hand during Q&A you can dial star one one.

[music]

Yeah.

Operator: Good morning, and thank you for standing by. Welcome to the Erytech Business Update and Financial Highlights for the Third Quarter of Year 2022. 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.

Good morning and thank you for standing by. Welcome to the Aeritech Business Update and Financial Highlights for the third quarter of year 2022.

At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 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, Jill Bayen, CEO of Aeritec.

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 will need to press star one one on your telephone.

Please be advised that today's conference is being recorded.

Operator: I would now like to turn the conference over to your speaker today, Gil Beyen, CEO of Erytech. Please go ahead.

Please go ahead.

Thank you. Good afternoon, good morning, 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.

Thank you.

Gil Beyen: Thank you. Good afternoon, good morning. 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 the webcast presentation can be found on the Investor Relations page of our website.

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.

We announced our business and financial update yesterday evening. This release and webcast presentation can be found on the Investor Relations page of our website.

This release and webcast presentation can be found on the Investor Relations page of our website.

Turning to slide two, before starting as usual I have to draw your attention to the disclaimer to remind you that today's call includes forward looking statements.

Gil Beyen: Turning to Slide 2, before starting as usual, I have to draw your attention to the disclaimer to remind you that today's call includes forward-looking statements. And as you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially.

Before starting as usual I have to draw your attention to the disclaimer.

To remind you that today's call includes forward looking statements.

And as you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially.

They all involve risks and uncertainties that could cause actual timings and results to differ materially.

Slide three, the agenda. Joining me on the call today are Dr. Imam El-Hariri, our Chief Medical Officer, and Eric Zouaier, our Chief Financial and Chief Operating Officer.

Gil Beyen: 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.

Joining me on the call today are Dr.

Our Chief Medical Officer, and Erik <unk>, 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 .

I will start with a short introduction and presents 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.

After which Erik 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 will be present.

Gil Beyen: So slide four, and this is really an update or an overview for anyone new to the company. I think most of you know, but for completeness, Erytech, the name says it's 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 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. But yes, 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 preclinical programs. We're still working on the encapsulation of the Erycap platform, but now working with physicals derived from the loaded red blood cells. Also preclinical programs in rare diseases and the other priority clearly is pursuing partnering options, more in a minute.

So slide four, 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 Aerotec. Aerotec, the name says it focused on the development of red blood cell based therapeutics.

Erytech, the name says it's 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

it's 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

We have been active in this field for quite some time, focused and developed the proof of concept with a product, ARIAS-PAS.

We have been active in this field for quite some time, focused and developed the proof of concept

developed the proof of concept

with 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. But yes, 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 preclinical programs. We're still working on the encapsulation of the Erycap platform, but now working with physicals derived from the loaded red blood cells.

is asparaginase encapsulated in red blood cells.

and for which we have had encouraging preclinical results in the ALL, acute lymphoblastic leukemia, and pancreatic cancer. But 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 preclinical programs. We're still working on the encapsulation, the ERCAPS platform, but now working with vesicles derived from these...

and for which we have had encouraging preclinical results in ALL acute lymphoblastic leukemia and pancreatic cancer. But yes, 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 preclinical programs. We're still working on the encapsulation of the Erycap platform, but now working with physicals derived from the loaded red blood cells.

But yes, 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 preclinical programs. We're still working on the encapsulation of the Erycap platform, but now working with physicals derived from the loaded red blood cells.

are from the loaded red dot cells.

the loaded red blood cells.

Red blood cells also.

also preclinical programs in rare diseases. And the other priority clearly is pursuing partnering options more in a minute.

Also preclinical programs in rare diseases and the other priority clearly is pursuing partnering options, more in a minute.

in a minute.

Gil Beyen: Quickly then to slide five, 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 and it is a fact that indeed in August we decided to no longer pursue our activities to try and obtained U.S. approval for prosper in a subsegment of ALL in Hypersensitive ALL. And this was based on feedback we've just had then received from the FDA for which it became clear that we needed additional clinical data, which in the competitive environment and the whole context of the specifics of indication was an impossible task for us.

Quickly then to slide five, the business highlights, the main news items.

business highlights.

The main news items of the third quarter and year to date.

of the third quarter and year to date.

The first one was already largely presented at our last call, 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. And 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.

Gil Beyen: The first one was already largely presented at our last call and it is a fact that indeed in August we decided to no longer pursue our activities to try and obtained U.S. approval for prosper in a subsegment of ALL in Hypersensitive ALL. And this was based on feedback we've just had then received from the FDA for which it became clear that we needed additional clinical data, which in the competitive environment and the whole context of the specifics of indication was an impossible task for us.

a subsegment of ALL in Hypersensitive ALL. And this was based on feedback we've just had then received from the FDA for which it became clear that we needed additional clinical data, which in the competitive environment and the whole context of the specifics of indication was an impossible task for us.

And this was based on feedback we've just had then received from the FDA for which it became clear that we needed additional clinical data, which in the competitive environment and the whole context of the specifics of indication was an impossible task for us.

an impossible task for us.

Another one also presented in September was that we had an, there was a non investigation as it's more worded by Facebook.

Gil Beyen: Another one also presented in September was that we had an -- there was a steering committee in the TRYbeCA-2, phase 2 trial in triple negative breast cancer, which saw good safety, but no efficacy signal towards a small number of patients because we stopped this trial prematurely. But still, there was not a signal based on which we said we should continue this activity. And the result of this combined then with the earlier setback in the pancreatic cancer phase 3 trial -- this was at the end of last year -- all of that together led us to the decision to stop the GRASPA or Eryaspase development altogether.

Yes.

steering committee in the Tribeca 2 phase 2 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...

steering committee in the TRYbeCA-2, phase 2 trial in triple negative breast cancer, which saw good safety, but no efficacy signal towards a small number of patients because we stopped this trial prematurely. But still, there was not a signal based on which we said we should continue this activity. And the result of this combined then with the earlier setback in the pancreatic cancer phase 3 trial -- this was at the end of last year -- all of that together led us to the decision to stop the GRASPA or Eryaspase development altogether.

signal based on which we said we should continue this activity. And the result of this combined then with the earlier setback in the pancreatic cancer phase 3 trial -- this was at the end of last year -- all of that together led us to the decision to stop the GRASPA or Eryaspase development altogether.

sort of a signal based on which we said we should continue this activity.

And the results of this combined then with the earlier setback in the pancreatic cancer phase 3 trial, this was the end of last year, all that together.

And the result of this combined then with the earlier setback in the pancreatic cancer phase 3 trial -- this was at the end of last year -- all of that together led us to the decision to stop the GRASPA or Eryaspase development altogether.

to the decision to stop the GRASPA or ARIESPA's development altogether.

led us to the decision to stop the GRASPA or Eryaspase development altogether.

The priorities of the company now.

Gil Beyen: The priorities of the company now, let's see. First of all, the cost restructuring -- cost reduction and restructuring. We launched this already as soon as we heard the news, but mainly after the sale of the Princeton facility. We have performed staff reductions in the U.S. and have also implemented now a restructuring plant, et plante sociale sculpt in France which is now fully implemented.

first of all, the deep cost restructuring, cost reduction and restructuring. We launched this already, as soon as we had the news, but mainly after the sale of the Princeton facility.

We launched this already as soon as we heard the news, but mainly after the sale of the Princeton facility.

as soon as we heard the news, but mainly after the sale of the Princeton facility.

we have performed staff reductions in the US and have also implemented now a restructuring plan, a plan social, it's called in France, which is now fully implemented.

We have performed staff reductions in the U.S. and have also implemented now a restructuring plant, et plante sociale sculpt in France which is now fully implemented.

and have also implemented now a restructuring plant, et plante sociale sculpt in France which is now fully implemented.

which is now fully implemented.

Gil Beyen: And so now, at the end of the implementation, which compared to the number of people at the time we announced the pancreatic phase-3 trial, which is end of last year, we're now at roughly 75% less than at that time. So small, steep reduction of the team size.

still at the end of the implementation, but compared to the number of people at the time we announced the pancreatic phase III trial.

at the end of the implementation, which compared to the number of people at the time we announced the pancreatic phase-3 trial, which is end of last year, we're now at roughly 75% less than at that time. So small, steep reduction of the team size.

which is end of last year, we are now at roughly 75% less than at that time. So a small, steep reduction of the team size.

which is end of last year, we're now at roughly 75% less than at that time. So small, steep reduction of the team size.

75% less than at that time. So small, steep reduction of the team size.

So small, steep reduction of the team size.

Gil Beyen: The second priority for the company and of the remaining 45-ish, 40 to 45 people, we have kept a core team in our R&D programs. So they're focusing on the second priority, our preclinical activities, especially on the vesicles -- the extracellular vesicles, exosome-like but now derived from red cells, where we see a lot of promise for immune oncology applications and potentially also for RNA and for other nonviral gene therapy.

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. So they're focusing on the second priority, our preclinical 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 all immuno-oncology applications, and potentially also for RNA and for other non-virals.

we have kept a core team in our R&D programs. So they're focusing on the second priority, our preclinical activities, especially on the vesicles -- the extracellular vesicles, exosome-like but now derived from red cells, where we see a lot of promise for immune oncology applications and potentially also for RNA and for other nonviral gene therapy.

So they're focusing on the second priority, our preclinical activities, especially on the vesicles -- the extracellular vesicles, exosome-like but now derived from red cells, where we see a lot of promise for immune oncology applications and potentially also for RNA and for other nonviral gene therapy.

immune oncology applications and potentially also for RNA and for other nonviral gene therapy.

for other nonviral gene therapy.

gene delivery. We have over the past months shown in vivo.

Gil Beyen: We have over the past months shown in vitro feasibility. The in vivo work is ongoing and 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. We already had, in fact rare disease programs while we were working on GRASPA, but they were sort of -- did not get much attention, so we're now reviving and giving them renewed attention.

The in vivo work is ongoing and we expect to be able to provide an update in the beginning or in the first quarter of next year. We are also working on rare disease programmes that we already had, in fact rare disease programmes, while we were working on GRASPA.

The in vivo work is ongoing and we expect to be able to provide an update in the beginning or in the first quarter of next year.

and we expect to be able to provide an update in the beginning or in the first quarter of next year.

We expect to be able to provide an update.

the beginning or in the first quarter of next year.

We're also working on rare disease programs.

We already had, in fact rare disease programs while we were working on GRASPA, but they were sort of -- did not get much attention, so we're now reviving and giving them renewed attention.

GRASPA, but they were sort of -- did not get much attention, so we're now reviving and giving them renewed attention.

But they did not get much attention, so we're now reviving, giving them renewed attention.

but they were sort of -- did not get much attention, so we're now reviving and giving them renewed attention.

reviving and giving them renewed attention.

It's renewed giving them renewed attention.

Also here, expect to be able to provide updates.

Gil Beyen: Also here, we expect to be able to provide updates in the first quarter of next year. And then the third and main priority of the company is we've announced it already after the phase 3 trial results. The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

in the first quarter of next year. And then the third and main priority of the company is we've announced it already after the phase 3 trial results. The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

in the first quarter of next year.

And then the third and main priority of the company is, we've announced it already after the

And then the third and main priority of the company is we've announced it already after the phase 3 trial results. The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

after the phase 3 trial results. The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

The phase three trial results is the search for strategic options. We realize that Eritec still has a lot to offer, but doesn't have a lead program anymore.

phase 3 trial results. The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

The search for strategic options, we realize that Erytech still has a lot to offer, but doesn't have a lead program anymore.

doesn't have a lead program anymore.

So the sale of our US production facility, the Princeton facility, to Catalan was a first step.

Gil Beyen: So 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 are trying to do here is to recapitalize on Erytech being a listed company with cash. Eric will provide an update.

And we are now working on.

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 are trying to do here is to recapitalize on Erytech being a listed company with cash. Eric will provide an update.

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 are trying to do here is indeed capitalize on EriTech being a listed company with cash. EriTech will provide an update with still a GMP facility with technology IP and a...

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 are trying to do here is to recapitalize on Erytech being a listed company with cash. Eric will provide an update.

Gil Beyen: But still the GMP facility with technology IP and a the core team -- the research core team also a corporate infrastructure that can support such a company in a combination.

and a research core team, also a corporate infrastructure that can support such a company.

the core team -- the research core team also a corporate infrastructure that can support such a company in a combination.

support such a company in a combination.

in a combination.

So that's it for the slide five for the highlights. I will stop here and hand over to Erik who will provide an update on the financials for the first nine months.

Gil Beyen: So 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.

It's 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 loose flow afterwards.

And we'll summarize the news flow afterwards.

Rick, all yours. Thank you, thank you Gilles. Good morning everyone, bonjour à tous.

Eric, all yours.

Eric Soyer: Thank you. Thank you, Gil. Good morning, everyone. Bonjour à tous. We're now reviewing the financial highlights of nine months period ended on September 30. We're on slide seven of the slide deck. And we're starting as usual with P&L information.

We're now reviewing the financial highlights of the nine months period that ended on September 30. We're on slide 7 of the slide deck. And we're starting, as usual, with T&L information.

We're now reviewing the financial highlights of nine months period ended on September 30. We're on slide seven of the slide deck. And we're starting as usual with P&L information.

And 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 multiple clinical development activities and also the deep restructuring of the company.

Eric Soyer: As already noted in our previous call for Q2 results, the financial results for the first nine months of '22 confirm its significant and accelerated decrease in operating expenses and cash utilization in connection with the completion and closure of multiple clinical development activities and also the deep restructuring of the company.

the company.

As a result, the net loss for the first nine months of 2022 was €6.2 million, which was a €35.4 million improvement over the same period of last year, reflecting the €24.4 million net gains on the sale of the Princeton facility.

Eric Soyer: As a result, the net loss for the first nine months of '22 was $6.2 million euro, which was a $35.4 million improvement over the same period of last year, reflecting the $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 $15.5 million, that's minus 33% year over year. It was minus 19% at the end of June. The cost reduction was mostly on R&D with a $14.4 million euro decrease in expenses related to the gradual termination of clinical programs, while G&A expenses also showed a $1.4 million decrease over last year.

$6.2 million euro, which was a $35.4 million improvement over the same period of last year, reflecting the $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 $15.5 million, that's minus 33% year over year. It was minus 19% at the end of June. The cost reduction was mostly on R&D with a $14.4 million euro decrease in expenses related to the gradual termination of clinical programs.

and the sharp decrease in operating expenses that show an accelerated decrease of 15.5 million that's minus 33% year over year it was minus 19% at the end of June .

And the sharp decrease in operating expenses that show an accelerated decrease of $15.5 million, that's minus 33% year over year. It was minus 19% at the end of June. The cost reduction was mostly on R&D with a $14.4 million euro decrease in expenses related to the gradual termination of clinical programs.

The cost reduction was mostly on R&D with a 14.4 million euro decrease in expenses related to the gradual termination of clinical programs, while GNA expenses also showed a 1.4 million decrease over the last year.

The cost reduction was mostly on R&D with a $14.4 million euro decrease in expenses related to the gradual termination of clinical programs.

while G&A expenses also showed a $1.4 million decrease over last year.

Total operating expenses of 31.2 million euro included an important provision of 2.5 million, mainly on the Lyon production facility and related to the end of the areas past operations, as well as a 1.9 million euro provision for restructuring relating to the staff protection plan in France.

Eric Soyer: Total operating expenses of $31.2 million Euro included an impairment provision of $2.5 million, mainly on the Lyon production facility and related to the end of Erytech operations as well as a $1.9 million euro provision for restructuring related to the [indiscernible] plan in France. Income tax included in '22, a provision of $3.8 million euro, still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis.

operations.

as well as a $1.9 million euro provision for restructuring related to the [indiscernible] plan in France.

Income tax included in '22, a provision of $3.8 million euro, still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis.

income tax included in 22, a provision of 3.8 million euro, still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis.

until further analysis.

We are now moving on to slide number 8 for comments on cash.

Eric Soyer: We are 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 $47.3 million euro or approximately $46.3 million U.S. dollars, compared with $33.7 million euro at the start of the year.

At the end of September this year, EriTech had cash and cash equivalents totaling 47.3 million euro or approximately 46.3 million US dollars compared with 33.7 million euro at the start of the year.

At the end of September this year, Erytech had cash and cash equivalents totaling $47.3 million euro or approximately $46.3 million U.S. dollars, compared with $33.7 million euro at the start of the year.

totaling $47.3 million euro or approximately $46.3 million U.S. dollars, compared with $33.7 million euro at the start of the year.

compared with $33.7 million euro at the start of the year.

The 13.6 million net increase in cash position during the first nine months of 22 was the result of the net cash of 37.6 million received from the sale of the Princeton facility.

Eric Soyer: The $13.6 million net increase in cash position during the first nine months of '22 was the result of the net cash of $37.6 million received from the sale of the Princeton facility. Also a $27.4 million cash utilization in operating and investing activities, of course excluding the sale of the Princeton facility and a $1.6 million generated in net financing activities, and that was including the $3 million euro prefunding of the expected '21 R&D tax credits.

Also a 27.4 million cash utilization in operating and investing activities, of course, excluding the sale of the Princeton facility, and a 1.6 million generated in net financing activities. And that was including the 3 million Euro pre-funding of the expected 21 R&D tax credits.

Also a $27.4 million cash utilization in operating and investing activities, of course excluding the sale of the Princeton facility and a $1.6 million generated in net financing activities, and that was including the $3 million euro prefunding of the expected '21 R&D tax credits.

R&D tax credits.

And finally, in the period, the variation of the US dollar against the euro led to a 1.7 million euro positive currency exchange impact.

Eric Soyer: And finally in the periods, the variation of the U.S. dollar against the Euro led to a $1.7 million euro positive currency exchange impact. As already mentioned, the company has initiated earlier this year, a deep restructuring and cost reduction program and these cost reductions have been further intensified with the help of the Graspa program and BLA process.

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 GRASPAP program and VLA process.

As already mentioned, the company has initiated earlier this year, a deep restructuring and cost reduction program and 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-24.

Eric Soyer: Considering these ongoing cost reductions, the company believes that its current cash position can fund its current programs and client's operating expenses to mid '24. This is of course, sort of a theoretical run rate as we will obviously not sit on this cash for 20 plus months or plan, as Gil mentioned that to restart the company on the new development pipeline with a strategic partner in which case the current projection as is will not be relevant anymore.

This is of course sort of a theoretical runway as we will obviously not sit on this cash for 20 plus months. Our plan is, Gilles 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.

This is of course, sort of a theoretical run rate as we will obviously not sit on this cash for 20 plus months or plan, as Gil mentioned that to restart the company on the new development pipeline with a strategic partner in which case the current projection as is will not be relevant anymore.

run rate as we will obviously not sit on this cash for 20 plus months or plan, as Gil mentioned that to restart the company on the new development pipeline with a strategic partner in which case the current projection as is will not be relevant anymore.

Now, 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.

Eric Soyer: Now and before we move onto Q&A, a quick wrap up of our key news flow and milestones expected 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 derived extracellular vesicles. We call this novel technology ERYCEV or or a Erycev. We expect to report on our preclinical results in a few months.

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 derived extracellular vesicles, we call this novel technology ARICEV or ARICEV, we expect to report on our preclinical results in a few months.

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 derived extracellular vesicles. We call this novel technology ERYCEV or or a Erycev. We expect to report on our preclinical results in a few months.

the focus on the ongoing preclinical programs and more particularly our program with red blood cell derived extracellular vesicles. We call this novel technology ERYCEV or or a Erycev. We expect to report on our preclinical results in a few months.

our program with red blood cell derived extracellular vesicles. We call this novel technology ERYCEV or or a Erycev. We expect to report on our preclinical results in a few months.

derived extracellular vesicles. We call this novel technology ERYCEV or or a Erycev. We expect to report on our preclinical results in a few months.

or a Erycev. We expect to report on our preclinical results in a few months.

And of course on the other end, an update on our partnering process was 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.

Eric Soyer: And 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. Variable options are under discussion and we expect to give further updates on this hopefully before the end of the year.

evaluating a number of strategic options to best leverage the company's assets and capabilities in a business combination with a strategic partner.

Variable 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.

Eric Soyer: 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, over to you.

Gilles, Iman, myself will be happy to answer any question you may have.

Gil, Iman, myself will be happy to answer any question you may have. Operator, over to you.

Operator Ricka Trinc, over to you.

Eric Soyer: Operator, over to you.

Over to you.

Thank you. As a reminder, to ask a question, you'll need to press star 1 1 on your telephone. Please stand by while we compile the Q&A roster.

Operator: Thank you. As a reminder, to ask a question you will need to press star one one on your telephone. Please standby while we compile the Q&A roster.

Our first question comes from Boris Baker with Cowen. Your line is open.

Operator: Our first question comes from Boris Peaker with Cowen. Your line is open.

Great, thanks for taking my questions and good morning or good afternoon.

Boris Peaker: Oh, great. Thanks for taking my questions. Good morning or good afternoon, depending on 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 new Erycev program, I don't know, over the next 6 to 12 months? Will we see any visibility into that clinic clinging to this program?

Good morning or good afternoon, depending on where you are.

Depending where you are.

I just have one simple question, and that is, are there any clinical data readouts specific...

I just have one simple question and that is, are there any clinical data readouts, specifically that we should be expecting particularly maybe from me new Erytech program, I don't know, over the next six to 12 months?

that we should be expecting.

particularly maybe from the

maybe from me new Erytech program, I don't know, over the next six to 12 months?

your new ARESF program over the next...

6 to 12 months.

Will we see any visibility into that clinically into this program?

Will we see any visibility into that clinic clinging to this program?

Gil Beyen: Hi Boris, good morning. Gil here. On Erycev or the preclinical programs, nothing to expect in the next 6 to 12 months. There's the preclinical still and still some work too, R&D. The preclinical readouts still is the ongoing respect trial, it's a phase one trial in first line pancreatic cancer, an ISG run by Georgetown University where the trial is still treating patients. And we heard from the PI that he wants to present this data at ASCO so that is in June or 9 months away.

Hi, Boris. Good morning. Gilles here. On every step of the preclinical programs, nothing to expect in the next 6 to 12 months. They're preclinical still and still somewhere to IND. The preclinical readout still is the ongoing respect trial. It's a phase 1 trial in first-time pancreatic cancer, an IST run by Georgetown University, where the trial is still treating patients. And we heard from the PI that he wants to present these data at ASCO.

Gil Beyen: On Erycev or the preclinical programs, nothing to expect in the next 6 to 12 months. There's the preclinical still and still some work too, R&D. The preclinical readouts still is the ongoing respect trial, it's a phase one trial in first line pancreatic cancer, an ISG run by Georgetown University

There's the preclinical still and still some work too, R&D. The preclinical readouts still is the ongoing respect trial, it's a phase one trial in first line pancreatic cancer, an ISG run by Georgetown University

an ISG run by Georgetown University

where the trial is still treating patients. And we heard from the PI that he wants to present this data at ASCO so that is in June or 9 months away.

And we heard from the PI that he wants to present this data at ASCO so that is in June or 9 months away.

Lawrence psychological

June 9 months away.

so that is in June or 9 months away.

Got it. Thank you very much for taking my question.

Boris Peaker: Got it. Thank you very much for taking my question.

Thank you very much for taking my question.

Thank you, Lord.

Gil Beyen: Thank you, Boris.

Operator: Thank you and there are no other questions in the queue. I'd like to turn the call back to Gil Beyen for closing remarks.

Thank you, and there are no other questions in the queue. I'd like to turn the call back to Jill Bagan for closing remarks.

Gil Beyen: No questions. Then I want to thank everyone for your participation, your attention and your continued support for Erytech. As always, we will keep you posted on progress and I wish you a nice rest of the day and speak soon at least, at the next call in a couple of months. Have a good day.

No questions, then I want to thank everyone for your participation, your attention and your continued support of EriTech. As always, we will keep you posted on progress and wish you a nice rest of the day.

I want to thank everyone for your participation, your attention and your continued support for Erytech. As always, we will keep you posted on progress and I wish you a nice rest of the day and speak soon at least, at the next call in a couple of months. Have a good day.

As always, we will keep you posted on progress and I wish you a nice rest of the day and speak soon at least, at the next call in a couple of months. Have a good day.

I wish you a nice rest of the day and speak soon at least, at the next call in a couple of months. Have a good day.

rest of the day and speak soon at least, at the next call in a couple of months. Have a good day.

speak soon at least, at the next call in a couple of months. Have a good day.

at least, at the next call in a couple of months. Have a good day.

Yeah, speak soon, at least at the next call in a couple of months.

So at least at the next call it couple of months.

Have a good day.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

youparticipatingmaynow.

[music]

[music].

Operator: Good morning, and thank you for standing by and welcome to the Aerotech business update and financial highlights for the third quarter of year 2022. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session. 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.

Good morning and thank you for standing by. Welcome to the Aeritech Business Update and Financial Highlights for the third quarter of year 2022.

At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.

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'd now like to turn the conference over to your Speaker today, Jill Ban C. E O of Aerie Tech. Please go ahead.

Please go ahead.

Thank you.

Good afternoon. Good morning, we'll go out.

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.

We announced our business and financial update yesterday evening and the <unk>.

This release and webcast presentation can be found on the Investor Relations page of our website.

Turning to slide two, before starting as usual I have to draw your attention to the disclaimer to remind you that today's call includes forward looking statements.

Turning to slide two.

Before starting as usual I have to draw your attention to the disclaimer.

To remind you that today's call includes forward looking statements.

And as you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially.

And as you know they all involve risks and uncertainties that could cause actual timings and results to differ materially.

Slide three, the agenda. Joining me on the call today are Dr. Imam El Hariri, our Chief Medical Officer, and Eric Zwier, our Chief Financial and Chief Operating Officer.

Slide three the agenda.

Joining me on the call today are Dr.

Our Chief Medical Officer, and Erik <unk>, 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 .

I will start with a short introduction and presents 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 .

So slide four and this is really an update ours or an overview for anyone new to the company I think most of you know, but for completeness, who is areas like the name says.

It's 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 every aspects

We have been active in this field for quite some time focused.

Developed the proof of concept with a product every us bus, which is asparaginase encapsulated in red blood cells.

is asparaginase encapsulated in red blood cells.

And for which we have had encouraging preclinical results in ALLL lymphoblastic acute lymphoblastic leukemia and pancreatic cancer.

and for which we have had encouraging preclinical results in the ALL, acute lymphoblastic leukemia, and pancreatic cancer. But as this will be a point on the next slide, we have recently decided not to pursue further development in this product. Focus is now on our preclinical programs. We're still working on the encapsulation, the ARICAPs platform, but now working with vesicles derived from these.

This will be a point on the next slide we have recently decided not to pursue further development in this with this product focus is now on our preclinical programs. We are still working on the encapsulation of the Aercap platform, but now working with physicals derived from this.

are from the loaded red dot cells.

From the loaded.

Red blood cells.

also preclinical programs in rare diseases. And the other priority clearly is pursuing partnering options more in a minute.

Also.

Preclinical programs in rare diseases and the other priority clearly is pursuing partnering options.

In a minute.

Quickly turning to slide five.

Quickly then to slide five, the business highlights, the main news items.

Business highlights.

The main news items of the third quarter and year to date.

of the third quarter and year to date.

The first one was already largely presented at our last call, is the fact that indeed in August , we decided to no longer pursue our activities to try and obtain a U.S. approval for CRASPA in a subsegment of ALL, in hypersensitive ALL. And 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.

First one was already largely presented at our last call is the fact that indeed in August we decided to no longer pursue our activities to try and obtain U S approval for prosper.

A sub segment of ALLL in Hypersensitive CLO.

And this was based on feedback we just had been received from the FDA for which it became clear that we needed additional clinical data, which in the competitive environment in the context of the specifics of indication.

An impossible task for us.

Another one also presented in September was that we had an, there was an,

Another one also presented in September was that we had and there wasn't.

Understood.

Steering committee and the Tribeca II phase II trial in Triple negative breast cancer, which saw good safety, but no efficacy signal towards 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.

And sort of a signal based on which we said we should continue this activity.

And the results of this combined then with the earlier setback in the pancreatic cancer phase 3 trial, this was the end of last year, all that together.

And the result of this combined with the earlier setbacks in the pancreatic cancer Phase III trial. This was at the end of last year all that together.

led us to the decision to stop the GRASPA or ARIUS-PA development altogether.

Led us to the decision to stop the grasp areas bus development altogether.

The priorities of the company now.

first of all, the deep cost restructuring, cost reduction and restructuring. We launched this already, as soon as we had the news, but mainly after the sale of the Princeton facility.

First of all the cost restructuring cost reduction and restructuring.

Launch this already.

Again as soon as we hit the news, but mainly after the sale of the Princeton facility.

we have performed staff reductions in the US and have also implemented now a restructuring plan, a plan social, it's called in France, which is now fully implemented.

We have performed staff reductions in the U S and have also implemented a restructuring plan a plant social holding per ounce.

Which is now fully implemented.

And so now.

still at the end of the implementation, but compared to the number of people at the time we announced the pancreatic phase III trial.

So 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 a small, steep reduction of the theme size.

End of last year, we are now.

Roughly 75% less than at that time, so small steep reduction of the same 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. So they're focusing on the second priority, our preclinical 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 all immuno-oncology applications, and potentially also for RNA and for other non-viral gene delivery.

The second priority for the company and of the remaining 45 ish 40 to 45 people.

We have kept a core team in.

Our R&D programs so.

Focusing on the second priority preclinical activities, especially on the physicals the extra cellular physical sits the <unk> zone like but now derived from from Red cells, where we held where we see a lot of promise for.

For immuno oncology applications and potentially also for RNA or other non viral gene delivery, we have over the past months shown in vivo.

we have over the past months shown in vitro feasibility.

<unk> visibility.

The in vivo work is ongoing and 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 programmes that we already had, in fact rare disease programmes, while we were working on GRASPA.

In vivo work is ongoing.

And we.

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.

We already had the effect of rare disease programs, while we were working on.

<unk>.

But they did not get much attention, so we're now reviving, giving them renewed attention.

But they were sort of did not get much attention. So we're now.

Reviving.

It's renewed giving them renewed attention.

Also here, expect to be able to provide updates.

So here, we expect to be able to provide updates.

in the first quarter of next year.

In the first quarter of next year.

And then the third and main priority of the company is, we've announced it already after the

And then the third and main priority of the companies we've announced it already.

After the.

The phase three trial results is the search for strategic options. We realize that Eritec still has a lot to offer, but doesn't have a lead program anymore.

The phase III trial results.

The search for strategic options, we realize that everything is still has a lot to offer.

It doesn't have a lead program anymore.

So the sale of our US production facility, the Princeton facility, to Catalan was a first step.

The sale of our U S production facility, the Princeton facility to Catlin was a first step.

And we are now working on.

And we're now working on different options, we did a broad screening we've zoomed in on the Q valuable options and hope to be able to provide an update before the end of the year or at least is that in the coming months. What we're trying to do here is indeed capitalized on everyday being a listed company.

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 EriTech being a listed company with cash. EriTech will provide an update with still a GMP facility with technology IP and a...

<unk> with cash Eric will provide an update.

But still the GMP facility with technology IP and a.

and a research core team, also a corporate infrastructure that can support such a company.

And the core team at research core team also a corporate infrastructure that can support such a company.

in a combination.

In a combination.

So that's it for the slide five for the highlights. I will stop here and hand over to Erik who will provide an update on the financials for the first nine months.

So thats.

It's for the slide five for the highlights.

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 loose flow afterwards.

And we'll summarize the news flow afterwards.

Rick, all yours. Thank you, thank you Gilles. Good morning everyone, bonjour à tous.

All yours.

Thank you Jill good morning, everyone.

We're now reviewing the financial highlights of the nine months period that ended on September 30. We're on slide 7 of the slide deck. And we're starting as usual with T&L information.

We'll now reviewing the financial highlights for the nine months period ended on September 30, we are on slide seven of the slide deck.

And we're starting as usual with P&L inflammation.

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 multiple critical development activities and also the deep restructuring of the company.

Already noted in our previous call for Q2 results the financial results for the first nine months of 'twenty to confirm its significant and accelerated decrease in operating expenses and cash utilization in connection with the completion and closure of multiple clinical development activities and also the deep restructuring of the.

<unk>.

As a result, the net loss for the first 9 months of 2022 was 6.2 million euro, which was a 35.4 million improvement over the same period of last year, reflecting the 24.4 million net gains on the sale of the Princeton facility.

As a result, the net loss for the first nine months of 22.

$6 2 million Euro, which was a $35 4 million improvement over the same period of last year, reflecting the $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 15.5 million that's minus 33% year over year it was minus 19% at the end of June .

And the sharp decrease in operating expenses that show an accelerated decrease of $15 5 million, that's minus 33% year over year it was minus 19%.

End of June .

The cost reduction was mostly on R&D with a 14.4 million euro decrease in expenses related to the gradual termination of clinical programs, while G&A expenses also showed a 1.4 million decrease over last year.

The cost reduction was mostly on R&D with a $14 4 million euros decrease in expenses related to the gradual elimination of clinical programs.

G&A expenses also showed a $1 4 million decrease over last year.

Total operating expenses of $31 2 million Euro included an impairment provision of $2 5 million, mainly on the loan production facility and related to the end of <unk>.

Operations as.

As well as a $1 9 million provision for restructuring related to the debt reduction plan and cross.

income tax included in 22, a provision of 3.8 million euro, still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis.

Income tax included in 'twenty to a provision of $3 8 million euro still reflecting the maximal potential tax impact of the capital gain from the sale of the Princeton facility until further analysis.

We are now moving on to slide number 8 for comments on cash.

We are now moving on to slide number eight for comments on cash.

At the end of September this year, EriTech had cash and cash equivalents totaling 47.3 million euro or approximately 46.3 million US dollars compared with 33.7 million euro at the start of the year.

At the end of September this year that would take our cash and cash equivalents totaling $47 3 million euro or approximately $46 3 million in U S dollars compared with $33 7 million at the start of the year.

The 13.6 million net increase in cash position during the first nine months of 22 was the result of the net cash of 37.6 million received from the sale of the Princeton facility.

The $13 6 million net increase in cash position during the first nine months of 'twenty. Two was the result of the net cash of $37 6 million received from the sale of the Princeton facility.

So a $27 4 million cash utilization in operating and investing activities of course, excluding the sale of the Princeton facility.

And a $1 6 million generated in net financing activities and that was including the 3 million Euro pre funding of the expected 'twenty one R&D tax credits.

And finally, in the period, the variation of the US dollar against the euro led to a 1.7 million euro positive currency exchange impact.

And finally in the periods the variation of the U S dollar against the Euro led to a $1 7 million euro positive currency exchange impacts.

Okay.

As already mentioned, the company has initiated earlier this year a deep restructuring and cost reduction program. And these cost reductions have been further intensified with the help of the GRASPAP program and VLA process.

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 <unk> program and BLA process.

Considering this ongoing cost reduction, the company believes that its current cash position can fund its current programs and plans operating expenses to mid-24.

Considering these ongoing cost reductions the company believes that its current cash position can fund its current program and plant operating expenses to mid 'twenty four.

This is of course sort of theoretical runway.

Not sit on this cash flow 20 plus months.

As you have mentioned that to restart the company on the new development pipeline with a strategic partner in which case the current projections.

<unk> will not be relevant anymore.

Now, and 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.

Now before we move onto Q&A, a quick wrap up of our key newfield and milestones expected 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 derived extracellular vesicles, we call this novel technology, ARICEV or ARICEV, we expect to report on our preclinical results in a few months.

Which all reflecting of course, the all key current priorities.

Nothing on women.

With the focus on the ongoing preclinical programs and more particularly.

Program with Red blood cell.

Derived extracellular vesicles recall this mobile technology.

CEB or a reserve we expect to report on our preclinical results in a few months.

And of course, on the other end, an update on our partnering process was 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.

And of course on the other end and 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.

With that I would like to thank you already very much for your attention and we will now open the call for Q&A.

GL EMR myself will be happy to answer any question you may have.

Gilles, Iman, myself will be happy to answer any question you may have.

Operator Rick, I bring it over to you.

Operator, Erica trend.

Over to you.

Thank you. As a reminder, to ask a question, you'll need to press star 1 1 on your telephone. Please stand by while we compile the Q&A roster.

Thank you as a reminder to ask a question you will need to press star one on your telephone please standby, while we compile the Q&A roster.

Our first question comes from Boris Baker with Cowen. Your line is open.

Our first question comes from Boris <unk> with Cowen Your line is open.

Great, thanks for taking my questions and good morning or good afternoon.

Oh, great. Thanks for taking my questions.

Good afternoon, depending where you are.

you

I just have one simple question, and that is, are there any clinical data readouts specific...

I just have one simple question and that is are there any clinical.

Data read out specifically that we should be expecting.

that we should be expecting.

particularly maybe from the

Particularly maybe from me.

your new ARESF program over the next...

Or is that program I don't know over the next six to 12 months.

6 to 12 months.

Will we see any visibility into that clinically into this program?

Will we see any visibility into that clinic plan to this program.

Hi, Boris good morning, Michelle here.

Hi, Boris. Good morning. Gilles here. On every step or the preclinical programs, nothing to expect in the next 6 to 12 months. They're preclinical still and still somewhere to IND. The preclinical readout still is the ongoing respect trial. It's a phase 1 trial in first-time pancreatic cancer, an IST run by Georgetown University, where the trial is still treating patients. And we heard from the PI that he wants to present these data at ASCO.

No on the reserve or the preclinical programs nothing to expect in the next six to 12 months.

Preclinical still and still some work to do R&D deep preclinical Readouts still is the ongoing respect to trial a phase one trial in first line pancreatic cancer.

<unk> run by Georgetown University.

The trial is still treating patients.

And we heard from the pie that we wanted to present these data at ESMO.

it.

June 9 months away.

<unk>.

What is it June nine months away.

Got it. Thank you very much for taking my question.

Got it.

Thank you very much for taking my question.

Thank you, Lord.

Thank you Laurie.

Okay.

Thank you, and there are no other questions in the queue. I'd like to turn the call back to Jill Bagan for closing remarks.

Thank you and there are no other questions in the queue I'd like to turn the call back to Jim <unk> for closing remarks.

No questions then.

Want to thank everyone for your participation and your attention and your continued support for Iridex.

We will keep you posted on progress.

Yes.

Mispriced.

Rest of the day.

Yeah, speak soon, at least at the next call in a couple of months.

<unk>.

Okay.

At least at the next call couple of months.

Have a good day.

This concludes today's conference call. Thank you for participating. You may now disconnect.

This concludes today's conference call. Thank you for participating you may now disconnect.

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