Xenetic Biosciences, Inc. · NASDAQ:XBIO
Xenetic Biosciences — Merger or Acquisition (March 2019)
34 slides from Xenetic Biosciences's merger presentation, Mar 4, 2019
Slide 1: Corporate Presentation
Enhancing lives with transformative therapies www.xeneticbio.com NASDAQ: XBIO Corporate Presentation February 2019 Filed by Xenetic Biosciences, Inc. pursuant to Rule 425 under the Securities Act of 1933, as amended, and deemed filed pursuant to Rule 14a - 12 under the Securities Exchange Act of 193
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation contains various “forward - looking statements . ” Forward - looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical fa
Slide 3: Additional Information and Where to Find It
ADDITIONAL INFORMATION AND WHERE TO FIND IT In connection with the Acquisition, the Company will file with the Securities and Exchange Commission (the “SEC”), a registra tio n statement on Form S - 4 that will include a combined proxy statement/prospectus. This communication is not a substitute for
Slide 4: Investment Highlights
Investment Highlights 4 Transformative acquisition positions Xenetic to address high value oncology market with innovative XCART platform XCART Platform 1 Expanding the potential of CAR T cell therapy • Proof - of - mechanism and preclinical evidence of target specificity • Expect to meet with regul
Slide 5: Pipeline and Platform Technologies
XCART Platform B - Cell Non - Hodgkin Lymphoma Meet with regulatory authorities to discuss development plan XBIO - 101 Progesterone Resistant Endometrial Cancer Data analysis Triple - Negative Breast Cancer Exploratory study of estrogen receptor and I - O biomarkers Immuno - Oncology Exploratory Pha
Slide 6: Experienced Management Team
Experienced Management Team 6 Jeffrey F. Eisenberg Chief Executive Officer & Director Life Sciences executive with over 20 years of successful track record in value creation in both private and public companies; former CEO of Noven Pharmaceuticals and responsible for 2 product launches and led Noven
Slide 7: Board of Directors
Board of Directors 7 Adam Logal Chairman CFO, OPKO Health; Former Director, VBI Vaccines; Nabi Biopharmaceuticals James Eric Callaway, Ph.D. Director Head of Development, Elan Pharmaceuticals; Developed the antibodies Tysabri and bapineuzumab Firdaus Jal Dastoor , FCS Director Fellow Member of The I
Slide 8: Scientific Advisory Board
Scientific Advisory Board 8 Dr. Matthew Frigault Medical Oncologist in the Hematologic Malignancy Program at the Massachusetts General Hospital Cancer Center, as well as Assistant Director of the Cellular Immunotherapy Program, serves as Instructor at Harvard Medical School Dr. Alexander Gabibov Hea
Slide 9: XCART Platform: Expanding the Potential of CAR T Cell Therapy
XCART Platform 1 Expanding the Potential of CAR T Cell Therapy 1: The Acquisition of the XCART platform is subject to closing. When filed, please see our Registration Statement on Form S - 4 for more details
Slide 10: CAR T Cell Therapy is Driving New Breakthroughs in the Treatment of Cancer
CAR T Cell Therapy is Driving New Breakthroughs in the Treatment of Cancer 10 New CAR T Treatment Giving Hope To Some Cancer Patients companies developing CAR T therapy 1 2 Approved CAR T Therapies Advancing Development High Value Acquisitions ~40 $11.9B acquired by for $9B acquired by for CAR T Cel
Slide 11: XCART Transforms CAR T Therapy
XCART Transforms CAR T Therapy 11 XCART constructs can target patient - specific tumor neoantigens Established proof - of - mechanism in B - cell lymphomas Potential to address multiple tumor types XCART is a proximity - based screening platform Derived from Scripps technology Proprietary cell - bas
Slide 12: XCART Platform Described In Science Advances
XCART Platform Described In Science Advances 12
Slide 13: XCART Shown to be Effective in B-Cell Lymphoma
XCART Shown to be Effective in B - Cell Lymphoma 13 XCART: Rationale for BCR Targeting Engineered to target a patient - and tumor - specific neoantigen B - cell receptor (BCR) on an individual patient’s lymphoma cells BCR signaling pathway • Central regulator of B - cell function • Promising antican
Slide 14: Market Opportunity – Non-Hodgkin Lymphoma Therapeutics
Market Opportunity – Non - Hodgkin Lymphoma Therapeutics Estimated 2018 US Incidence of NHL: 75,000 1 14 1: https://seer.cancer.gov/; 2: Crump, M et al . Outcomes in refractory diffuse large B - cell lymphoma: results from the international SCHOLAR - 1 study. Blood 2017 Aug 3; 3: Market Reports Worl
Slide 15: Unmet Need in Follicular Lymphoma (FL)
Unmet Need in Follicular Lymphoma (FL) 15 1: Casulo C. et al , J. Clin. Oncology , 2015 33:2516 - 2522 2: Montoto et al. J Clin Oncol. 2007 Jun 10;25(17):2426 - 33. Epub 2007 May 7 Time from Risk - Defining Event (months) Survival Probability (%) FL Treatment Timeline 5 - year Survival Rate: 90% Med
Slide 16: Unmet Need in Diffuse Large B-Cell Lymphoma (DLBCL)
Unmet Need in Diffuse Large B - Cell Lymphoma (DLBCL) 16 12 Months 48 Months 24 Months 36 Months 0 Month (50%) Xplant Ineligible (50%) Relapse (20%) (80%) Diagnosis DLBCL 70% 2 nd Line Ablation/ BMT Relapse/ Refractory 50% 50% DLBCL Treatment Timeline 30% Primary Refractory Initial XCART Opportunity
Slide 17: Selection of Peptide-CAR Constructs Specific to an Individual's Tumor BCR
Selection of Peptide - CAR Constructs Specific to an Individual’s Tumor BCR 17 XCART Proof of Mechanism: Workflow Selection of peptide - CAR constructs specific to an individual’s tumor BCR • Lymph node biopsy sample is isolated from a patient with follicular lymphoma • Collected tumor cells used fo
Slide 18: Cyclopeptide-CAR T Cells Selectively Kill Raji Cell Lines Expressing Target BCRs
Cyclopeptide - CAR T Cells Selectively Kill Raji Cell Lines Expressing Target BCRs • Human CD8+ T cells were transduced with Lentiviral vectors coding for one of pepFL1 - CAR, pepFL2 - CAR, pepFL3 - CAR or CD19 - CAR constructs 18 XCART Proof - of - Mechanism: Patient Specificity Raji cells (Raji -
Slide 19: Induction of CTL in Ex Vivo Biopsy Material
Induction of CTL in Ex Vivo Biopsy Material 19 XCART Proof - of - Mechanism: Patient Specificity pepFL1 - CAR T cells specifically lysed cells from pt - FL1 Myc - CAR T and Mock CAR T control cells: No lytic activity pepFL2 - CAR T cells specifically lysed cells from pt - FL2 pepFL3 - CAR T showed n
Slide 20: pepFL1-CAR T in In Vivo Tumor Model of Raji-FL1 Cell Line
pepFL1 - CAR T in In Vivo T umor Model of Raji - FL1 Cell Line 20 XCART Proof - of - Mechanism: Efficacy and Selectivity NOD SCID (CB17 - Prkdc scid / NcrCrl ) mice were engrafted subcutaneously with 5x10 6 Raji - FL1 cells (Raji cells expressing the malignant BCR of Patient pt - FL1) pepFL1 - CAR T
Slide 21: XCART is Differentiated from CD19 CAR T Therapies for NHL
XCART is Differentiated from CD19 CAR T Therapies for NHL 21 Tissue Specificity Off - Tumor Toxicity Tumor Antigen Escape Recognizes only patient - and tumor - specific neoantigen Decreased antigen burden implies lower risk of CRS and Neurotoxicity No expectation of B - cell aplasia Targets an antig
Slide 22: XBIO-101: Phase 2 Oncology Asset
XBIO - 101 Phase 2 Oncology Asset
Slide 23: XBIO-101: Current Development Status and Opportunities
XBIO - 101: Current Development Status and Opportunities 23 XBIO - 101 XBIO - 101 in Context of Immuno - Oncology Preclinical and human clinical evidence for XBIO - 101 as an immunomodulator • IFN induction • Modulation of other immune pathways (including TLR9) • Supporting nonclinical and 21 foreig
Slide 24: PolyXen PSA Technology Platform Enables Next Generation Biologic Drugs
PolyXen ™ PSA Technology Platform Enables Next Generation Biologic Drugs
Slide 25: PolyXen: Next Generation Delivery Platform for Biologics
PolyXen : Next Generation Delivery Platform for Biologics 25 Polysialylation employs the biological polymer polysialic acid (PSA) to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs Seeking to build a pipeline of partnerships utilizing PolyXen Key Features • Retention of na
Slide 26: Summary
Summary
Slide 27: CAR T Value Indicators Suggest Potential Significant Upside
CAR T Value Indicators Suggest Potential Significant Upside 27 1: As of January 23, 2019 EBV+ PTLD following HCT Phase 3 $1.6B UCART19 Phase 1 $669M rGBM & Libtayo ® Phase 2 $285M MB - 101 IL13R α2 - specific CAR Phase 1 $80M $11.9B acquired by for $9B $567M acquired by for acquired by for Acquisiti
Slide 28: A Compelling Investment Opportunity
A Compelling Investment Opportunity 28 Innovative XCART platform 1 addressing high - value oncology market XBIO - 101 Phase 2 oncology asset • Clinical body of data sufficient for Phase 2 studies in multiple indications • Potential applications in immuno - oncology PolyXen Shire Agreement • Shire gr
Slide 29: Supplemental Information
Enhancing lives with transformative therapies www.xeneticbio.com NASDAQ: XBIO Supplemental Information
Slide 30: Identification of Individualized BCR-Targeting CAR T Constructs
Identification of Individualized BCR - Targeting CAR T Constructs 30 Selection of cyclopeptide - CARs specific to a targeted BCR: 7aa cyclopeptide library hinge CD28 MT/ cyt OX - 40 cyt CD3 zetta cyt Lymphoma BCR VH/VL IgG1 hinge PDGFR TM Activation FACS anti - CD69 Library of immortal Jurkat human
Slide 31: Selection and Isolation of Individualized Cyclopeptide-CAR Fusion Constructs
• Patient - specific BCRs were cloned from malignant sections of lymph node biopsies in 3 Follicular Lymphoma (FL) patients • Several rounds of selection resulted in discovery of three patient - specific, cyclopeptide - containing CAR constructs Selection and Isolation of Individualized Cyclopeptide
Slide 32: Staining by pepFL1 Peptide Against pt-FL1 and pt-FL4 Cell Lines
Staining by pepFL1 Peptide Against pt - FL1 and pt - FL4 Cell Lines 32 X - CART Proof - of - Mechanism: Patient and Target Specificity BCR - specific peptides selectively stain parental cells from corresponding patient’s biopsy material • More than 60% of cells in the biopsy sample are B - cells tar
Slide 33: pepFL1-CAR T in In Vivo Metastasis Model
pepFL1 - CAR T in In Vivo Metastasis Model 33 Raji - FL1 cells (green) on Day 35 after tumor implantation in mice treated by CD19 - CAR T, FL1 - CAR T and Myc - CAR T CD19 - CAR T and FL1 - CAR T prevent development of metastasis • Bioluminescent imaging of organ - specific metastasis Raji - FL1 cel
Slide 34: pepFL1-CAR T Cells in Mouse Tumor Models of pt-FL1 Cells
pepFL1 - CAR T Cells in Mouse Tumor Models of pt - FL1 Cells 34 X - CART Proof - of - Mechanism: In Vivo PK CAR T staining by human CD8 - specific antibodies Black arrows indicate CD19 - CAR T, pepFL1 - CAR T or Myc - CAR T infiltration into the tumor pepFL1 - CAR T and CD19 - CAR T cells are presen
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