Business Update & Financial Results for Q1 2018

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1 Business Update & Financial Results for Q May 15, 2018

2 Disclaimer The statements made in this presentation may include forward-looking statements regarding the future operations of ERYTECH Pharma S.A., including estimates of target market opportunity, timing of planned clinical trials and results from those trials, regulatory strategy and timing of planned regulatory submissions, manufacturing capabilities and strategy for expansion of the ERYCAPS platform. Although we believe that the expectations contained in this presentation are reasonable, these forward-looking statements are only estimations based upon the information available to ERYTECH Pharma S.A. as of the date of this presentation. Except as required by law, we expressly disclaim any responsibility to publicly update or revise our forward-looking statements, whether as a result of new information, future events or otherwise. Thus, the forward-looking statements herein involve known and unknown risks and uncertainties and other important factors such that actual future operations, opportunities or financial performance may differ materially from these forwardlooking statements. Undue reliance should not be placed on forward looking statements, which speak only as of the date hereof. All forward-looking statements contained herein are qualified in their entirety by the foregoing cautionary statement. 2

3 ERYTECH business update and Q financial results Business update Financial results Q News flow and upcoming milestones 3

4 Leveraging red blood cells to improve cancer treatment 1 Innovative and versatile ERYCAPS technology platform Encapsulation of therapeutic compounds in red blood cells (RBC) Broadly applicable; strong intellectual property protection 2 Focused on cancer metabolism, targeting altered metabolic pathways Inducing tumor starvation by sustained depletion of certain amino acids Potential for synergistic effects with other therapies Targeting indications with high unmet medical need Acute lymphoblastic leukemia (ALL) Pancreatic ductal adenocarcinoma (PDAC) Triple negative breast cancer (TNBC) Lead product candidate eryaspase (GRASPA ) in late development Positive Phase 2/3 clinical trial in ALL; EU MAA (1) resubmitted Positive Phase 2b clinical trial in PDAC; preparing launch of Phase 3 Preparing launch of Phase 2 clinical trial in TNBC Attractive long-term growth opportunities and strategic optionality Various platform opportunities beyond current lead programs ALL & AML partnered in EU and Israel; ERYP holds other commercial rights (1) Marketing Authorization Application 4

5 Clinical and preclinical pipeline Mode of action Product Candidate/ PROGRAM Drug substance Indication Discovery Preclinical Phase 1 Phase 2 Phase 3/ Pivotal Application for Regulatory Approval Commercial Rights ALL Europe (2) Israel Cancer metabolism Tumor starvation eryaspase (GRASPA (1) ) Asparaginase PDAC TNBC Solid tumor TBD erymethionase Methionine-γlyase Solid tumors Enzyme therapies ERYZYME Therapeutic enzymes Metabolic diseases Immunotherapy ERYMMUNE Tumor antigens TBD Arrow indicates most advanced study within an indication or program; more detail is provided in subsequent slides (1) Brand name for eryaspase in Europe and Israel (2) Recordati holds commercial rights to ALL and AML in Europe 5

6 Key 2018 and recent business highlights Finalized Pivotal Phase 3 trial design for eryaspase in second line metastatic pancreatic cancer; set up activities ongoing; expected start of enrollment in Q3 Finalizing proof-of-concept Phase 2b trial design for triple negative breast cancer; expected start of patient enrollment in Q3 Reported positive U.S. Phase 1 trial results with eryaspase in adult acute lymphoblastic leukemia at AACR 2018; discussion with FDA upcoming in Q2 Presented pre-clinical data on combination of eryaspase and erymethionase Expanded executive management team with the hiring of Alex Dusek as VP of Commercial Strategy Cash position of million ($211.6 million) as of March 31,

7 Second line pancreatic cancer Positive Phase 2b data in 2L metastatic pancreatic cancer Data demonstrated significant improvements in both overall survival (OS) and progression-free survival: OS HR of 0.60 (p = 0.009), PFS HR of 0.59 (p = 0.011) Phase 3 trial in 2L metastatic pancreatic cancer on track for launch in Q3 Eryaspase in combination with standard chemotherapy (gem/abraxane or irinotecan-based), compared to standard chemotherapy alone Approximately 500 patients in the United States and Europe Primary endpoint: overall survival (OS) Main secondary endpoints: PFS, ORR, DCR, QoL, biomarkers, and safety Interim analysis planned at approximately two-thirds of events Set-up activities ongoing First patient expected in the third quarter of

8 Triple negative breast cancer (TNBC) and other solid tumors Finalizing design of Phase 2 in TNBC Proposed proof of concept Phase 2 trial will evaluate eryaspase in combination with gemcitabine/carboplatin, compared to gemcitabine/carboplatin alone Approximately 60 patients in EU and the U.S. in patients previously untreated for their metastatic or inoperable locally recurrent disease Primary endpoint: objective response rate Interim analysis is foreseen Set up activities are ongoing and start of patient enrollment is expected in the third quarter of 2018 Other solid tumors Expansion of clinical development of eryaspase to first-line pancreatic cancer and other solid tumor indications Program updates are expected later in 2018 and early

9 Acute lymphoblastic leukemia (ALL) Full results from U.S. Phase 1 clinical trial in first line adult ALL reported Full results from the U.S. Phase I presented at the annual meeting of the American Association for Cancer Research (AACR). Trial conducted at five clinical sites across the United States Clinical data demonstrate that eryaspase was well-tolerated when combined with CALGB 8811 protocol Based on pharmacokinetic and safety findings, the recommended dose for further clinical development was determined to be 100 U/kg EU marketing authorization application in relapsed/refractory ALL ongoing Review ongoing; CHMP opinion expected by the end of the year Preparing to discuss next steps in ALL with the FDA towards end of this quarter 9

10 Preclinical programs Preclinical toxicology studies with erymethionase, methionine-γ-liase encapsulated in red blood cells, ongoing; preparing for initiation of Phase 1 study by end of the year Preclinical combination data of eryaspase with erymethionase were presented at the 2018 AACR Annual Meeting, demonstrating promising in vitro and in vivo combination treatment in a gastric cancer model with tumor growth inhibition in-vivo and decreased tumor cell viability in vitro Preclinical proof-of-principle studies of ERYZYME, encapsulating enzymes used in certain enzyme therapies, and ERYMMUNE, encapsulating tumor antigens within red blood cells as a potentially innovative approach to cancer immunotherapy, are ongoing. Updates expected during 2H

11 Executive management strengthened Appointed Alex Dusek as Vice President Commercial Strategy and member of the executive team To ensure commercial product preparedness and lay the groundwork for commercial success of our late-stage product candidates worldwide, with initial focus on the United States Mr. Dusek brings 25 years of experience in market access, product marketing and sales across small biotech start-ups and multi-national pharmaceutical companies, including Argos Therapeutics, Bayer HealthCare Pharmaceuticals, and United Therapeutics 11

12 Q financial results (Cumulative figures in '000 - unaudited) Q (3 months) Q (3 months) Var in K Var in % Revenues Other income (18) -1% Total operating income (18) -1% Research and development (7 729) (5 847) (1 882) 32% General and administrative (2 734) (1 906) (828) 43% Total operating expenses (10 463) (7 753) (2 710) 35% Total operating loss (9 259) (6 531) (2 728) 42% Financial income Financial expenses (2 592) (19) (2 572) Financial income (loss) (2 513) 21 (2 533) % Loss before tax (11 771) (6 510) (5 261) 81% Income tax 27 (13) % Net loss (11 744) (6 523) (5 221) 80% Q consolidated net loss of 11.7 million, an increase of 5.2 million yoy Total operating expenses of 10.5 million, an increase of 2.7 million resulting from increased development activities and the strengthening of the team 2.5 million financial loss related to the EUR currency translation of the USD portion of the company s cash position 12

13 Cash position and shareholder base Cash position of million ($211.6 million) as of March 31, 2018 Raised 194 ($226) million in capital in 2017 and began trading on the Nasdaq Select Global Markets on November 10, 2017 Cash position of ($223) million at December 31, million decrease in cash position in the first quarter of Net cash utilization of 11.2 million (Operating/Capex/Financing) million currency translation impact on US$ positions Shareholder structure unchanged since IPO capital raise: EU#Retail# #!10$15%%!! US#Ins'tu'onal# 45/50%# EU#Ins'tu'onal# #!45$50%!! 13

14 Key upcoming milestones expected in 2018 q Meeting with the FDA to discuss next steps in ALL q Launch of pivotal Phase 3 trial in 2L pancreatic cancer in Europe and U.S. q Launch of Phase 2 proof-of-concept trial in TNBC q Advance U.S. registration-directed activities for ALL (subject to FDA feedback) q CHMP feedback on MAA resubmission for GRASPA in R/R ALL q Initiation of Phase 2 proof-of-concept trial in first-line pancreatic cancer q Initiation of Phase 1 clinical trial with erymethionase q Updates on preclinical pipeline programs 14

15 THANK YOU QUESTIONS? ERYTECH Pharma SA 60 Avenue Rockefeller Lyon France ERYTECH Pharma Inc 1 Main Street Cambridge, MA USA investors@erytech.com

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