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00

02 Good day and thank you for standing by. Welcome to the ERYTECH Business Update and Financial highlights for the second quarter of year twenty twenty one. At this time, all participants are in listen only mode. [Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions] 00

32 I'd now like to hand the conference over to your speaker today, Gil Beyen, Chief Executive Officer. Please go ahead.

00

39 Thank you, Liz. Good afternoon, good morning, [Foreign Language]. Thank you for joining us for our earnings call to discuss the highlights and financials for the first half of this year. I hope everyone is well and safe today, wherever you may be taking today's call. We announced our business and financial update yesterday evening September twenty. The press release and the first half earnings presentation can be found in the Investors sections of our website. 01

08 Joining me today on this call are Dr. Iman El-Hariry, our Chief Medical Officer, together with me here in Boston; and Eric Soyer, our Chief Financial and Chief Operating Officer dialing in from Leon. 01

22 And switching to slide two and before starting I would like to draw your attention to the disclaimer to remind you that today's calls includes forward looking statements such as relating to the company’s operations, anticipated timelines, and financials. As you know, they all involve risks and uncertainties that could cause actual timings and results to differ materially. 01

45 Now switching to slide three, the agenda for the call I will as usual start with a short introduction and present the key business highlights of the year and the year-to-date, and focusing on the more recent ones, the ones that we issued after our last call in May. Iman will then provide an update on the status and the progress of our four clinical programs to date; after which Eric will present the financial results for the first half of the year. He will also summarize the expected milestones for the coming year before we then open up the lines for Q and A; and all three of us will be available to answer your question afterwards. 02

23 Moving to slide four, introduction for anyone new to the company, here is a brief overview of ERYTECH. We are the leader in red blood cell-based therapeutics, as you know. Our focus is on targeting cancer cells altered amino acid metabolism, an increasingly important and exciting area of cancer therapy. 02

45 In this area, we have late stage clinical programs, pancreatic cancer, triple negative breast cancer, and acute lymphocytic leukemia. And as I noted at our last call, the upcoming quarter, the fourth quarter is truly a key quarter for everything with some key inflection points for the company. We have, as you know, we have four programs ongoing, two of them potentially pivotal, potentially supporting an application for regulatory approvals. And for both of them, we expect important news this quarter. More on that in a minute. 03

25 Just to summarize the introduction, we are producing our product in two fully operational facilities one in Leon, to serve the European market; and one in Princeton for the U.S. market. And also in terms of total based very balanced between Europe and U.S. with a Euronext and a Nasdaq listing with roughly fifty/fifty shareholder base. 03

48 And then the highlights for the year, slide five. Again, it has been a bit critical steps forward since our last call or first half of the year, to bring our lead product areas passed the patients in need and this both in Europe and the United States. And for highlights, I'd like to mention starting with TRYbeCA-1, of course, our Phase three trial in second line pancreatic cancer. 04

14 Towards the final readout is continuing in full force over the summer and is continuing. And now the eyes are really on the results, which we continue to expect in the fourth quarter of this year. So, TRYbeCA-1 is to our knowledge the largest clinical trial ongoing in second-line metastatic pancreatic cancer and has the potential if successful to lead to a treatment paradigm shift against this terrible disease. 04

41 The study was initiated three years ago. And so now we are indeed fully – the eyes focused on top line results, not that far away. And Iman will tell more about this. Then our second highlight is acute lymphocytic leukemia. More specific in ALL patients who developed hyper sensitivities to pegylated asparaginase. 05

09 Progressing, we had positive data as you know, I have presented at ASH, we then had the dialogue ongoing with the FDA met with a pre-BLA meeting in June. After which in July, we confirmed our intention to submit a BLA by year-end is obviously subject to successful completion of remaining test as discussed during the pre-BLA meeting. 05

32 Also in June, no, this was in July. We were pleased that we then were granted the Fast Track designation for the treatment of ALL, and so now the teams are working indeed to the BLA submission before the end of the year. 05

48 Third highlights, back to pancreatic cancer, but now, first line, and highlights from our IST trial that is ongoing in Georgetown, University, the trail completed its first dose of three patients already before our previous call. In the meantime, the second dose is fully enrolled, and we are eagerly awaiting the final results on safety, if everything continues to go as we have seen so far, we should be able to determine the MTD shortly. 06

24 And then lastly on the slide, the successful financing, thirty million registered direct offering that was done in May that prolonged our cash rate into the second quarter, but also here, I will leave to Eric who will provide more detail shortly. 06

42 On the next slide, slide six. You see all of this summarized in an overview. I will not repeat. You see the check marks, lot of achievements over the past months of the year. And then indeed a concentration of milestones, some key ones in the fourth quarter, history results and BLA submission in ALL, but also significant and defining milestones in the coming twelve months or so. 07

09 I’ll stop here, hand over to Iman and provide additional color and details on our clinical programs and their expected platform. Iman, the floor is yours.

07

20 Thanks you, Gil. Good morning, United States. Good afternoon, Europe. So, I’ll provide a quick update and overview on our three main indications with [Indiscernible] the pancreatic cancer, triple-negative negative, as well as the ALL indication. So starting slide number eight, you have seen this slide before. This is our [Indiscernible] on a slide, [Indiscernible] which is in combination with chemotherapy in second line advanced pancreatic cancer. 07

59 As you know this study is our Phase 3 pivotal trial, five hundred patients enrolling patients with stages three and stage four disease with good performance thesis and these patients were randomized to receive chemotherapy with/without eryaspase. At that point, chemotherapy was a menu of two, either [Indiscernible]. As applicable trial, the primary end point is over survival. And we have all expect the second endpoints particularly Q1 is progression free survival. Their investigators assessment, as well as objective response [Indiscernible] also at quality of life in safety and biomarkers. 08

51 The study operationally was actually executed in living countries in Europe, as well as United States almost over, almost one hundred sites. Speaking in this trial and was co-lead by Professor Pascal Hammel and Professor Hidalgo in United States. 09

15 Just also to remind you of the study plant into the statistical design. So study is set to look at an improvement in overall survival with a hazard ratio of zero point seven two five in favor of additional eryaspase treatment. 09

39 This is – moves on – we can survive in the control arm of six months. And so we're looking at improvement from six to roughly eight point three months in the active. So this is a plan for the study. 10

00 So moving to slide number 9. Just to give you a quick highlights what we have done so far. Study have completed enrollment end of last year, and we ended up with five hundred and twelve patients in total. 10

15 We actually were very happy with the study enrollment. This was a major achievement not only for the company, but course for the patients who participated in the trial, despite the pandemic that hit all of us back in early twenty twenty. 10

32 So – which also didn't have major impact in terms of the environment or the quality of the patients participating in this trial. The study had an [Indiscernible] award in the [Indiscernible] met four times during the life of the study so far. The first three meetings where fifty reviews, there were no safety issues. 10

55 And then the last one was conducted in last February of this year, and this was our first and only interim analysis for efficacy, but also safety review. Based on their recommendation, the study continued to final analysis. 11

14 We are expecting the trial results in the first quarter of this year. Where I continue are working day and night to make sure that we have the data cleaning and the results planned as guided to the market. I also wanted to make sure that just to confirm that we continue to be blinded to the study. So, and that is – it's a trial and we need to integrity of the trial. 11

49 Moving to slide 10, switching gears also in the same indication though, this is our investigator initiatives at Phase one study in first line pancreatic cancer, which is by Dr. Noel in Georgetown University. So the study is reaching, I would say safety and tolerability of adding eryaspase in combination with modified FOLFIRINOX for in this setting. 12

19 FOLFIRINOX is becoming increasingly popular of choice in that setting and therefore it needs lots of good rationale for us to assist the combined ability of our drug with this chemotherapy regimen. 12

36 As a phase one trial, the primary endpoint is fifty and really recommendations to those for future study in that setting. Studies started beginning of this year, started with those [Indiscernible] of seventy five units, but actually, it's [Indiscernible] unit per kilogram and just it is cycle there. 13

07 So, as you know, those as which we are using in our indications is hundred unit per kilogram. So, we started with slightly lower [Indiscernible] there was no DLT observed under for the side and in fact is connected to the second and final dose cohort, which is one hundred unit per kilogram. 13

32 This cohort has already fully enrolled and we think for the last patient in that cohort to clear for any dose limiting for [Indiscernible]. If that is the case, hopefully soon, we'll be able to declare our recommended Phase 2 dose, which hope you will be the one hundred units per kilogram. 13

54 So, we are expecting these results, again the confirmation, again in – mainly in the first quarter of this year. So that covers the pancreatic indications to moving. Also moving to slide number 11, we also had, we've been at the beginning of this month where Professor Hidalgo and Doctor Noel [Indiscernible] lots of questions where addressed and physically a key outcome of this webinar is that, number one. Pancreatic cancer continues to be unmet medical need. 14

40 You know, [Indiscernible] so far only approved the drug in second line setting. And also so there is certainly new room for new treatments and improving survival in this patient. So, moving to slide number 12, so switching gears now to our second indication, which is triple-negative breast cancer that another highly unmet needs. 15

09 So, we are stuck with a proof of concept trial led by Dr. Awada in Jules Bordet in Belgium in Brussels. And this study is small randomized trial, sixty five patients and important in first and second line setting to assist the clinical activity of [Indiscernible] when added to [Indiscernible]. 15

37 So for this trial is a European only trial, and we have a student committee app that they made, should viewed the safety profile so far. And again, no issues, given this is again our first combination, and we did not do at least one trial. So, we are expecting our interim data, initial/interim data in the first half of twenty twenty two. 16

09 Moving to slide fifteen. So this will be our next indication and this is for us a very exciting opportunity for several reasons. Really it’s addressing again, another unmet need, it's important for the patients who develop hypersensitivity reactions to pegylated asparaginase which is a standard of [Indiscernible] these patients. 16

39 So the ALL indication is based on a NOPHO-sponsored Phase 2 trial that was presented last year at ASH twenty twenty. And in that trial, which around fifty five patients in total, patients who have developed [purposes just] (ph) actions will switch to receive any experience with the same backbone chemotherapy to be able to complete intended courses of asparaginase therapies. 17

14 The trial shows that asparaginase activity was maintained in most if not all of those patients with a very good safety profile. More importantly the convenience of treatment since [Indiscernible] is a drug that is given once every two weeks that provides also a better quality of life for particularly for the [Indiscernible]. 17

43 With this, it really, it recaps our – it confirms our view that we do have an [Indiscernible] need in issues which present about fifteen percent to twenty percent of this population. While there are two drugs approved that we need, which has suffered longer term supply shortage, but newly approved [Indiscernible]. 18

12 It's still there is an important need for – a critical need to have an additional option for those patients and a little bit ability at least to afford the continuous of treatment. So, with asparaginase we end up with two administrations per month as compared to twelve to fifteen patients. 18

32 And you can imagine the impact of this number of administration, particularly, if you have kids one year order, two year. Also, it is certainly a factor that needs to be considered. The positive news for us so far that we have made with [Indiscernible] last three months ago, this is our [Indiscernible] meeting. And soon after, we have been granted the first track for ALL, for us very important as it is in our continuous dialogue with the FDA, and that's really the whole value of Fast Track designation. 19

14 We have guided before that we intend to have our submission expected in the first quarter. And this will be contingent on our successful completion of all the remaining activities. 19

29 So with this, I will stop here and then hand over to Eric Soyer, our Chief Financial and Operating Officer, who would provide us with the financial update and then news flow. So over to you Eric.

19

48 Thank you. Thank you very much, Iman. Good morning, everyone. We're now moving to slide fifteen of that slide deck, reviewing the financial highlights for the first half of this year, and was talking with P and L information. 20

07 As you can see, the net for the first half of twenty one was million and was down seven million minus twenty percent year over year, with a six point four million decrease minus eighteen percent in operating loss and million increase in financial income. 20

29 The six point four million euro decrease in operating loss was attributable to the five point six million decrease in preclinical and clinical development expenses, and of course, that's concurrent with the completion of patient enrollment in the company's phase three trial in pancreatic cancer, TRYbeCA-1. 20

49 Also, zero point three million euro decrease in G and A expenses and a zero point four million euro increase in other income mostly to R and D tax credits. The zero point six million increase in financial results was mostly related to foreign currency gains on the U.S. dollar. 21

13 And now we're moving to the next slide, number sixteen, for comments on cash. As of June thirty twenty one, ERYTECH had cash and cash equivalents totaling forty six point three million, which is approximately fifty four point nine million dollars and that's compared with forty four point four million euro, approximately fifty four point four million dollars on December thirty one last year and thirty seven point four million euro on March thirty one this year. 21

48 That's a one point four million increase in cash position during the first half of twenty one and that was the result of a thirty two point nine million euro net cash utilization, including thirty two point six million in operating activities and zero point three million in investing activities. 22

06 Also a thirty point one million euro generated in financing activities and that's including a eight million dollar replacement in the U. S. Food companies at the markets or ATM, equity financing program for net proceeds of six point four million euro, also a thirty million dollar reduce direct offering to net proceeds of twenty two point nine million and the drawdown of two tranches there are the [Indiscernible] the Program, the financing agreement that was signed with us in last year with net proceeds of five point seven million euro. 22

48 And finally, we have the of the U.S. dollar against the euro and that led to a zero point seven million euro, but achieved currency catching back. Moving to the next slide, seventeen, with the work on our most recent financing initiatives. You remember that on April twenty nine this year, we announced the registered direct financing with several healthcare focused institutional and accredited investors, with the placement of ADS’, American Depositary Shares at seven point two five dollars that's six point zero one euro per ADS and also associated with the seventy five percent foreign coverage. The two [Indiscernible] price of seven euro and zero point five zero dollars per share. 23

37 This reduced our direct financing associated with nine OCABSA tranches that's what’s called to date has extended cash horizon to Q2 next year, Q2 twenty twenty two. This cash horizon includes possibly the further extended to Q3 twenty two if the company further utilizes the OCABSA agreements. Of course, assuming incorrect market price and of course, subject to the regulatory limits of twenty percent dilution. 24

07 Finally, moving to the next slide, eighteen. I want to quickly summarize the upcoming key milestones before we'll start the Q and A session. That's of course, the top line results for TRYbeCA-1, the Phase 3 trial of eryaspase in pancreatic cancer and as explained by Iman, we expect those top line results quite soon in Q4 twenty twenty one. 24

35 We also, before the end of the year, have the potential BLA filing of eryaspase that's for hypersensitive patients of ALL patients. Again, looking forward to potentially finding the BLA dose here before the end of the year. 24

52 Also we'll have the determination of MTD, the Maximum Tolerable Dose in the respect the phase one trial in first-line pancreatic cancer, also before the end of the year. And then towards the first half of next year, we look forward to potential BLA filing for eryaspase in second-line pancreatic cancer, following the top results of TRYbeCA1 and also the data from the Phase 2 trial in breast cancer in the current ongoing TRYbeCA2 trial and that's also expected in the first half of twenty two. 25

33 With that, I would like to thank you already for your attention, and we will now open the call for any questions you may have. Again, I will be repeating myself and reminding any of you would like to ask question in French that you are of course very welcome to do so. [Foreign Language]. Operator, that’s now over to you.

26

06 [Operator Instructions] We have a question from Boris Peaker with Cowen.

27

02 Good morning. Can you hear me?

27

04 Yes, Boris. Good morning. How are you?

27

08 Good. How are you? Question that comes up frequently is, how does the patient enrollment in your pivotal pancreatic cancer compare to the Phase 2 study in terms of geography, age, or any other characteristics as well as any kind of follow-up care differences?

27

24 I’ll leave this to Iman to answer.

27

28 Hi, Good morning, Boris. So compared to the Phase one to the Phase two trial and the overall patient preferences, there are highly similar to what we have because of the inclusion, exclusion criteria. The difference here is, which we don’t believe is going to have any impact is the Phase two trial who is [Indiscernible] on these study, but the trial naturally with a trial in Europe and United States. 28

02 So that is just geographic difference. France remains our highest enrolling country in the phase three trial followed Spain. So with that in mind, we actually, compared to the Phase two trial, if you remember, what patients achieved for FOLFIRINOX or [Indiscernible] in the first-line, so almost ninety percent of our patient in the second-line version, [Indiscernible] is therapy in the phase three trial that we expecting also to have more patient receiving [asparagine] (ph) in the second line is still going to be ninety percent. 28

48 If just fixed, probably would be two-thirds to one-third and that’s what would be the difference. We have two in ours and that's actually the same view from Professor Hidalgo. It confirms also our view, which is we don't believe that the backbone chemotherapy will make really much of a difference in terms of the activity of eryaspase in combination with either choices. 29

22 But otherwise for some performance status is the same, you know of course progression of the first-line strategy, and many other inclusion, exclusion criteria is virtually the same.

29

39 Great. Well, thank you very much and we all look forward to the big data reveal. Thanks for taking my question.

29

46 Thank you, Boris.

29

49 And I'm not showing any further questions at this time.

29

56 I think then, if no further question I think we must have been very clear. And so, I want to thank you all for your attention, for your continued support. And as Boris said, it's now indeed looking forward to the data in the next quarter to come. So, we'll obviously keep you posted as always. In the meantime, we wish you a great day and great afternoon in Europe. Thank you, all. Take Care. Bye, bye.

30

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