Celyad Oncology Sa · EURONEXT:CYAD
Celyad Oncology Sa — Celyad — Investor Presentation (September 2019)
27 slides from Celyad Oncology Sa's investor presentation, Sep 4, 2019
Slide 1: Corporate Presentation September 2019
Corporate Presentation September 2019 EXHIBIT 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation may contain forward-looking statements, including statements regarding the safety and efficacy of our drug product candidates and the manufacturing methods used to manufacture these drug product candidates; statements concerning the ongoing and planned cl
Slide 3: Clinical-stage Biopharmaceutical Company Focused on CAR-T Therapies
Clinical-stage Biopharmaceutical Company Focused on the Development of CAR-T Therapies Lead candidate is autologous CAR-T therapy, CYAD-01, which leverages the natural killer receptor, NKG2D, currently in Phase 1 trial for the treatment of r/r AML and MDS First-in-class, non-gene edited allogeneic T
Slide 4: Continuing the Advancement of CAR-T Therapies
Continuing the Advancement of CAR-T Therapies Accelerate the clinical development program for autologous NKG2D-based CAR-T therapies for the treatment of r/r AML and focus on path to commercialization Today Tomorrow Beyond Leverage our innovative allogeneic approaches including TIM for CYAD-101, nov
Slide 5: Advancing CAR-T Therapy Pipeline
Advancing CAR-T Therapy Pipeline Target Product Preclinical IND Submission Design Phase 1 Study AML: Acute myeloid leukemia; mCRC: Metastatic colorectal cancer; MDS: Myelodysplastic syndrome; MM: Multiple myeloma; r/r: relapse/refractory. CyFlu: cyclophosphamide and fludarabine; FOLFOX: leucovorin,
Slide 6: Background on NKG2D Receptor
Background on NKG2D Receptor
Slide 7: Development of Novel NKG2D-based CAR-T
Development of Novel NKG2D-based CAR-T NKG2D is an activating receptor expressed on natural killer (NK) cells which plays an important role in protection against infection and cancer The receptor binds to eight stress induced ligands including: MICA, MICB, ULBPs 1-6 NKG2D ligands are absent or expre
Slide 8: NKG2D AML / MDS Program
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Slide 9: Interim Analysis from THINK Trial Demonstrates Clinical Activity of CYAD-01
CRh CRi mCR SD SD CRi (1) (2) Anti-leukemic activity observed Interim Analysis from THINK Trial Demonstrates Clinical Activity of CYAD-01 Without Preconditioning Chemotherapy Interim results as of January 4, 2019. CRh: Complete response with partial hematological recovery; CRi: Complete response wit
Slide 10: r/r AML/MDS Program – Summary of Ongoing Trials
r/r AML/MDS Program – Summary of Ongoing Trials CR: Complete response including CRh (Complete response with partial hematological recovery) or CRi (Complete response with incomplete marrow recovery); SD: Stable disease. First three injections of CYAD-01 separated by one-week intervals, while the sec
Slide 11: Recent Developments for r/r AML and MDS Program
Recent Developments for r/r AML and MDS Program CyFlu: Cyclophosphamide and fludarabine; FDA: U.S. Food and Drug Administration; FAMHP: Federal Agency for Medicines and Health Products. IND: Investigational New Application. Submitted Chemistry, Manufacturing, and Control (CMC) amendments related to
Slide 12: Highlights of OptimAb Manufacturing Process
Highlights of OptimAb Manufacturing Process for r/r AML and MDS Program OptimAb process drives improved survival in an aggressive AML model, where CYAD-01 dose is titrated for minimal activity Enriches for T-cells with Memory-like Phenotype OptimAb manufacturing process maintains an earlier memory p
Slide 13: NKG2D Solid Tumor Program
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Slide 14: mCRC Program – Summary of Clinical Data
PR: Partial response; SD: Stable disease; RECIST: Response Evaluation Criteria in Solid Tumors. alloSHRINK trial enrolling patients with unresectable metastatic colorectal cancer, refractory to FOLFOX chemotherapy. mCRC Program – Summary of Clinical Data THINK THINK CyFlu SHRINK alloSHRINK (1) Produ
Slide 15: CYAD-101 – First Non-gene Edited Allogeneic CAR-T
CYAD-101 – First Non-gene Edited Allogeneic CAR-T Leveraging TIM-mediated Inhibition of TCR Signaling for the Treatment of Solid Tumors Endogenous TCR/CD3 complex CYAD-101 The expression of TIM results in the competitive inhibition of CD3z and reduces signalling of the TCR complex leading to the pot
Slide 16: CYAD-200 Series – Novel, Allogeneic CAR-Ts
CYAD-200 Series – Novel, Allogeneic CAR-Ts
Slide 17: Celyad Targets CD3ζ to Generate Allogeneic T-cells
Celyad Targets CD3ζ to Generate Allogeneic T-cells CD3ζ is the rate-limiting factor to the TCR complex moving to the cell surface and an attractive target (i.e. shRNA, TIM) TCR complex is responsible for GvHD Elimination of the TCR complex is necessary for creating allogeneic CAR-T therapies TCRα (T
Slide 18: Developing a Novel, Non-gene Edited Allogeneic CAR-T Platform
Exclusive agreement with Horizon Discovery Group Horizon’s SMARTvector technology mimics endogenous mature microRNA shRNA allows knockdown of gene expression via RNA interference Developing a Novel, Non-gene Edited Allogeneic CAR-T Platform Based on Horizon’s shRNA SMARTvector Technology TCR: T-cell
Slide 19: shRNA vs. CRISPR-Cas9: Equivalent Knockdown of TCR
Cell Surface TCR Complex Intensity of TCRα/β TCR Stimulation Assay shRNA targeting CD3ζ reduces TCR expression and cytokine response shRNA vs. CRISPR-Cas9: Equivalent Knockdown of TCR TCR: T-cell receptor; shRNA: short hairpin RNA.
Slide 20: Controlled GvHD of Allogeneic CAR Despite T Cell Expansion
Controlled GvHD of Allogeneic CAR Despite T Cell Expansion Survival Persistence ** Mann-Whitney U -Test p-value of 0.0017; **** Mann-Whitney U-Test p-value of <0.0001. Mean Weight No evidence of major weight loss – a typical characteristic of GvHD induction In vivo protection of GvHD similar to CRIS
Slide 21: Trio of Disruptive, First-in-Class, Non-Gene Edited Allogeneic CARs
Trio of Disruptive, First-in-Class, Non-Gene Edited Allogeneic CARs BCMA CAR-T for multiple myeloma Evaluate shRNA approach with validated target Potential best-in-class allogeneic approach given increased persistence vs. gene edited candidates Expected to enter the clinic by mid-2020 CYAD-211 CYAD-
Slide 22: Cell Therapy Manufacturing
@&) Celyaa Cell Therapy Manufacturing
Slide 23: Proprietary 11,000 sq. ft. Manufacturing Facility
Proprietary 11,000 sq. ft. facility 94% manufacturing success rate in 2018 vs. 75% in 2017 Capabilities Support Clinical Development and Future Product Launch Streamlined centralized logistics to supply both U.S. and E.U. Over 600 billion cells produced in 2018 33 Patients treated in 2018 vs. 16 in
Slide 24: Strategy and Financials
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Slide 25: Strong Intellectual Property
Strong Intellectual Property In May 2017, Celyad granted Novartis a non-exclusive license for allogeneic TCR-deficient CAR-T cells patents related to two undisclosed targets Deal terms: Undisclosed upfront payment with $96 million in milestones plus royalties on commercial U.S. sales Celyad retains
Slide 26: Upcoming Milestones
Upcoming Milestones First Half 2020 CYAD-01 in r/r AML: Enrollment of first patient in cohort 3 of DEPLETHINK trial with OptimAb manufacturing process CYAD-101 in mCRC: Additional data from alloSHRINK trial CYAD-01 in r/r AML: Results from cohort 11 of THINK trial as well as cohort 3 from DEPLETHINK
Slide 27: Financial Snapshot
Financial Snapshot Cash, cash equivalents and short-term investments: €33.7 million ($38.3 million) as of second quarter ended June 30, 2019 Current cash expected to support the company’s activities into mid-2020 Basic Shares Outstanding: 11.9 million Ticker: Nasdaq (CYAD) and Euronext Brussels & Pa