Beyondspring, Inc. · NASDAQ:BYSI

Beyondspring — Investor Presentation (May 2017)

36 slides from Beyondspring's investor presentation, May 24, 2017

  1. Slide 1: Transformational Science Advancing Oncology

    Transformational Science Advancing Oncology

  2. Slide 2: Disclaimer

    Disclaimer This presentation contains forward-looking statements about BeyondSpring Inc. (“BeyondSpring” or the “Company”). Forward looking statements are based on our management’s beliefs and assumptions and on information currently available to our This presentation contains forward-looking statem

  3. Slide 3: Business Highlights: Corporate Overview

    Business Highlights Corporate Overview Neutropenia Prevention

  4. Slide 4: Corporate Overview

    * Corporate Overview Lead drug candidate Plinabulin with two indications in pivotal studyPrevention of Neutropenia caused by chemotherapy regimensNon Small Cell Lung Cancer (NSCLC) in patients with measurable lesionsDual-track development in US and China, supported by one global study Follow-on indi

  5. Slide 5: Plinabulin Pipeline Overview

    * Plinabulin Preclinical Phase 1 Phase 2 Phase 3 Status Plinabulin Prevention of Neutropenia(in chemo induced Neutropenia) Study 105 (docetaxel) IND Initiation 2Q 2017First Data Readout: 2H 2017 Study 106 (TAC) First Data Readout: 1H 2018 NSCLC: Measurable lung tumor (+ Docetaxel) Initiation 2Q 2016

  6. Slide 6: Plinabulin: Novel Structure and Novel IO Target

    * Plinabulin Dendritic Cell Neutropenia Prevention Effects Plinabulin: Novel Structure and Novel IO Target (GEF-H1) JNK Activation Rho Activation Immune – Related Anticancer Effects Plinabulin Kashyap A et al. Keystone Meeting，Mar. 2017Wang Y et al. FEBS J. 2016; 283: 102-111 300 derivatives

  7. Slide 7: Neutropenia Prevention

    Business. Highlights Neutropenia Prevention Corporate Overview

  8. Slide 8: Chemotherapy-Induced Neutropenia: An Underserved Market

    * Chemotherapy-Induced Neutropenia Causes: Neutropenia Treatment With G-CSF Causes: Bacterial related mortalitiesDelays in chemo dosingChemo Dose reductionsEarly termination of chemo Enlarged spleenAcute respiratory distress syndromeAnaphylaxisSickle cell disorderBone pain Addition to docetaxel led

  9. Slide 9: Severe Neutropenia Seen After Docetaxel Monotherapy

    * Severe Neutropenia Seen After Docetaxel Monotherapy Source: Quartino et al Invest New Drugs 2012; 30:833-845 Neutropenia Is Marked By: Severe InfectionsSepsisHospitalizationsHigh Mortality Cycle 1 Docetaxel Treatment Model Duration of Severe Neutropenia (DSN) refers to the number of days with neut

  10. Slide 10: Phase 2 Data Supports Favorable Product Profile

    * Phase 2 Data presented at ASH December 2016 Docetaxel Monotherapy DSN Estimate Model Based on Nadir- Cycle 1 Day 8 Phase 2 Data Supports Favorable Product Profile P < 0.0003 33.3% 4.6% * ~5% Both 20mg and 30mg Plinabulin cohort p-value <0.0003* Planned Phase 3 doseGrade 4/Severe Neutropenia: ANC <

  11. Slide 11: Efficacy Differentiation: Plinabulin vs. G-CSF

    * Efficacy Differentiation: Plinabulin vs. G-CSF Percentage of Patients Experiencing Grade 3 and 4 Neutropenia† Percentage of Patients Experiencing Grade 3 and 4 Neutropenia† Percentage of Patients Experiencing Grade 3 and 4 Neutropenia† Percentage of Patients Experiencing Grade 3 and 4 Neutropenia†

  12. Slide 12: Plinabulin: Differentiated from G-CSF in Neutropenia Prevention

    * Plinabulin: Differentiated from G-CSF in Neutropenia Prevention

  13. Slide 13: Plinabulin Neutropenia Clinical Program (Study 105)

    * Plinabulin Neutropenia Clinical Program (Study 105) Neulasta 0.6 mg/m2 (n=10) Plinabulin 5 mg/m2 (n=10) Plinabulin 10 mg/m2 (n=10) Plinabulin 20 mg/m2 (n=10) Arm 1Arm 2Arm 3Arm 4 Phase 2 Portion Phase 3 Portion Plinabulin 20 mg/m2* (n=75) *Planned Phase 3 Dose Neulasta 0.6 mg/m2 (n=75) CurrentFirs

  14. Slide 14: Plinabulin Neutropenia Clinical Program (Study 106)

    * Neulasta 0.6 mg/m2 (n=20) Plinabulin 10 mg/m2 (n=20) Plinabulin 20 mg/m2 (n=20) Arm 1Arm 2Arm 3 Phase 2 Portion Phase 3 Portion Neulasta 0.6 mg/m2 (n=60) Plinabulin 20 mg/m2 (n=60) *Planned Phase 3 Dose Plinabulin Neutropenia Clinical Program (Study 106) H1 2017Study to Initiate H1 2018 First Data

  15. Slide 15: Indication: Prevention of All Chemo-induced Neutropenia

    * Indication: Prevention of All Chemo-induced Neutropenia For concurrent administration with a myelosuppressive chemotherapeutic regimen in patients with non-myeloid malignancies for the prevention of chemotherapy induced neutropenia (with Study 105 and 106) Plinabulin’s mechanism of action (MOA) is

  16. Slide 16: General Overview

    Business. Highlights General Overview Neutropenia Prevention

  17. Slide 17: NSCLC: Large Market Opportunity for Plinabulin

    * NSCLC: Large Market Opportunity for Plinabulin Lung cancer is a leading cause of death worldwide~1.8 million diagnoses globally (87% have NSCLC)Nearly 1/3 of global patients are in ChinaDespite multiple approved therapies, the lung cancer treatment market remains fragmented, marked by modest survi

  18. Slide 18: Phase 2 Data: Durable Response and Extended Survival Benefit

    * Phase 2 Data: Oral Presentation at ASCO-SITC Meeting (Feb.2017) Durable Response and Extended Survival Benefit of 4.6 Months * We attribute the non-significant P-value to a small number of patients in each treatment arm

  19. Slide 19: Plinabulin + Nivolumab (PD-1 Antibody) for NSCLC

    * Plinabulin + Nivolumab (PD-1 Antibody) for NSCLC Animal studies provide indications of an immune MOA, which primarily acts through activation and proliferation of tumor antigen-specific CD4 T-cells, a white blood cell active in immune responses. Combo of Plinabulin and PD-1 antibody in immune comp

  20. Slide 20: Plinabulin Clinical Program in Cancer

    * Plinabulin Clinical Program in Cancer Exploring The Synergy of Plinabulin with Standard of Care Therapies in Multiple Patient Sub-Groups Plinabulin + Docetaxel*EGFR wild typePD-1/PD-L1 failed patients includedPhase 3: 550 patients to be enrolled(80% from China) Plinabulin+ PD-1 Antibody**PD-L1+Pha

  21. Slide 21: Investment Highlights

    Investment Business Highlights Neutropenia Prevention Highlights

  22. Slide 22: Seasoned Leadership Team

    * Seasoned Leadership Team Lan Huang, PhD: Co-Founder, Chairman & Chief Executive OfficerCo-founded clinical CRO Paramax and spearheaded its sale to global CRO RPS, Co-founded Wuxi MTLH Biotech, and sold self-designed peptide drug China rights to Shanghai Pharmaceutical companyBoard member of Oncolo

  23. Slide 23: Unique Access to Large China Market

    * Unique Access to Large China Market

  24. Slide 24: Plinabulin Commercial Strategy

    * China U.S./ Europe Seek broad indication from U.S. FDA in preventing Neutropenia, and in NSCLC in patients with measurable lung lesions Partner with one or more global pharmaceuticals companies for both Neutropenia and NSCLC indications Pursue accelerated development in China for NSCLC indicationB

  25. Slide 25: BeyondSpring Inc. (BYSI) NASDAQ IPO

    * BeyondSpring Inc. (BYSI)–NASDAQ IPO 3/9/2017 IPO & Concurrent Private Placement: $54.3 M ($48 M net)Investors Included:HuaRong, $150 B fund, largest Asset Management Co. in ChinaSangel, top 10 Biotech Focused Fund in China Fosun, $70 B Investment Conglomerate

  26. Slide 26: Expected Company Milestones

    * Expected Company Milestones 6 Months 12-18 Months 24-30 Months P3 FinalNeutropenia NSCLCIND submission P3 PD-1 ComboBPI-004 [IO]Ubiquitination Technology Platform asset: Fred Hutchinson/UW collaboration P3 InterimNeutropenia NSCLCDataPD-1 ComboIND submission BPI-002 [IO] P2 DataNeutropenia All fun

  27. Slide 27: Thank You!

    * Thank You!Contact: Lan Huang, Ph.D.lhuang@beyondspringpharma.comBeyondSpring Inc.28 Liberty Street, 39th Floor, New York, NY 10005Tel: 646-305-6387 | Fax: 646-219-9660

  28. Slide 28: Addendum

    * Addendum

  29. Slide 29: Robust Patent Estate

    Robust Patent Estate =5 additional US provisional global patent applications pending with the potential for protection to 2038 =72 granted Composition and Usage Patents for Plinabulin in 34 countries through 2025 =*Composition of matter patent to 2025 (up to 2030 with possible patent term extension)

  30. Slide 30: Additional Assets

    Additional Assets Fred Hutchinson/UW Collaboration ¢ Ubiquitination Technology: One approach is using a “molecular glue” to bind ubiquitin ligase to the target E3 ligases for oncogenes; collaborating with Dr. Zheng, HHMI Investigator, University of Washington. * Dr. Huang is the person who solved th

  31. Slide 31: Plinabulin + Docetaxel in NSCLC: Phase 1/2 Trial

    * Patients included:2nd/3rd line NSCLC, stage 3b/4n=163 Docetaxel 75mg/m2n=55 Docetaxel 75mg/m2 + Plinabulin 30mg/m2n=50 Docetaxel 75mg/m2n=18 Docetaxel 75mg/m2 + Plinabulin 20mg/m2n=40 Cohort 1: 30mg/m2 Cohort 2: 20mg/m2 Endpoints:Primary: Overall Survival (OS)Safety (includes Neutrophil count) Com

  32. Slide 32: Plinabulin's Neutropenia Benefit (Cycle 1-4)

    * Plinabulin’s Neutropenia Benefit (Cycle 1-4) Plinabulin’s Effect in Preventing Grade 4 and Grade 3 Neutropenia is Persistent Grade 3 Neutropenia Cycle 1 Cycle 2 Cycle 3 Cycle 4 Blue: Docetaxel alone (N=73)Red: Docetaxel + Plinabulin (N=90) Grade 4 Neutropenia

  33. Slide 33: Safety Data (Phase 2, NSCLC, Well Tolerated)

    * 30 DN(n=50） 20 DN (n=40) 20+30 D(n=73） Nausea 48;4 40;0 39;0 Fatigue 52;4 30;3 40;10 Diarrhea 58;8 35;5 33;6 Constipation 36;0 28;0 29;1 Anorexia 34;0 25;3 33;0 Pyrexia 30;0 23;0 26;2 Vomiting 34;4 35;0 25;1 Cough 22;0 33;0 32;0 Alopecia 28;0 25;0 33;0 Dyspnea 22;4 28;5 25;14 Neutropenia 8;8 8;5 3

  34. Slide 34: Study Design: Docetaxel (Study 105)

    * Study 105 Design: Docetaxel Neulasta 0.6 mg/m2 (n=10) Plinabulin 5 mg/m2 (n=10) Plinabulin 10 mg/m2 (n=10) Plinabulin 20 mg/m2 (n=10) Arm 1Arm 2Arm 3Arm 4 Phase 2 Portion Phase 3 Portion Interim Analysis at n=50/Arm  Primary Endpoint: DSN in Cycle 1 Non-Inferiority Margin: 0.65 days Plinabulin 2

  35. Slide 35: Statistics for Superiority in Phase 3 Portion Study 106

    * Neulasta 0.6 mg/m2 (n=20) Plinabulin 10 mg/m2 (n=20) Plinabulin 20 mg/m2 (n=20) Arm 1Arm 2Arm 3 Phase 2 Portion Phase 3 Portion Final Analysis at n=60/ArmSequential Analysis (DSN cycle 1)Non-InferioritySuperiority Neulasta 0.6 mg/m2 (n=60) Plinabulin 20 mg/m2 (n=60) *Current RP3D Numeric Results

  36. Slide 36: Plinabulin + Docetaxel Phase 3 Trial for NSCLC

    * Docetaxel +Plinabulin Plinabulin + Docetaxel Phase 3 Trial for NSCLC Patient Criteria:Patients with at least 1 measurable lung lesionPD-1/PD-L1 antibody failures (stratified)EGFR wild type, mutations not eligible; no restriction on histologyOne prior platinum-based chemotherapy; no restriction on

BeyondSpring — Investor Presentation (May 2017) on 6ix