Beyondspring, Inc. · NASDAQ:BYSI

Beyondspring — IPO Roadshow (February 2017)

44 slides from Beyondspring's IPO roadshow presentation, Feb 28, 2017

  1. Slide 1: Transformational Science Advancing Oncology

    Transformational Science Advancing Oncology

  2. Slide 2: Forward-Looking Statements

    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 management. Such statements are subject to known and unknown

  3. Slide 3: Agenda

    Agenda General Neutropenia Overview Prevention NSCLC BusinessHighlights Summary

  4. Slide 4: General Overview

    General Overview Plinabulin: History • Acquired from Nereus, a discoverycompany, after Phase 1/2 trial inNSCLC indication • Nereus will be issued BeyondSpringshares equal to 10% of fully-dilutedequity capitalization immediatelyprior to IPO Plinabulin: Late Stage • Synthetic analog of the natural Hal

  5. Slide 5: Pipeline Overview

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

  6. Slide 6: Seasoned Leadership Team

    Seasoned Leadership Team Lan Huang, PhD: Ramon Mohanlal, G. Kenneth Lloyd, Gordon Schooley, Richard Brand, Co-Founder, MD, PhD: Chief PhD: Chief Scientific PhD: Chief MBA: Chief Chairman & Chief Medical Officer Officer Regulatory Officer Financial Officer Executive Officer • More than 20 years • Gre

  7. Slide 7: Neutropenia Prevention

    General Neutropenia Overview Prevention NSCLC BusinessHighlights Summary 6

  8. Slide 8: Plinabulin's Target is Tubulin in Microtubules

    Plinabulin’s Target is Tubulin in Microtubules Cell Cytoskeleton Consists of Polymerized Tubulin a1Tub Immune - Related Anticancer Effects GTP b1Tub GDP Plinabulin Neutrophil Rescue Effects a2Tub Vascular Disruptive Effects b2Tub Wang Y et al. FEBS J. 2016; 283: 102-111 7Singh AV et al. Blood 2011l

  9. Slide 9: Plinabulin's Detailed Mechanism of Action

    Plinabulin’s Detailed Mechanism of ction Plinabulin Rho Activation JNK Activation Immune - Related Anticancer Effects Neutropenia Prevention Effects Dendritic Cell 8

  10. Slide 10: Plinabulin + Docetaxel in NSCLC: Phase 1/2 Trial

    Plinabulin + Docetaxel in NSCLC: Phase 1/2 Trial Completed by Nereus - CRO Quintiles; >70% Western Patient Population; Randomized Phase 2 portion of Phase 1/2 trial Cohort 1: 30mg/m2 Docetaxel 75mg/m2 n=55 Docetaxel 75mg/m2+ Plinabulin 30mg/m2 Patients included: 2nd/3rd line NSCLC, stage 3b/4 n=163

  11. Slide 11: Severe Neutropenia after Docetaxel Monotherapy

    Severe Neutropenia after Docetaxel Monotherapy Day 8 Cycle 1 DAYS • Severe Infections • Sepsis • Hospitalizations Source: Quartino et al InvestNew Drugs 2012; 30:833-845 • High Mortality 10

  12. Slide 12: Phase 2 Data: Neutrophil Counts in Cycle 1

    Phase 2 Data: Neutrophil Counts in Cycle 1 Day 8 Data of Phase 2 Plinabulin ITT, cohorts 20 mg and 30 mg with lab values  Effect of Plinabulin dose on cycle 1 day 8 Safety (ITT, 20 mg + 30 mg cohorts) Adverse events Sepsis Severe infections Docetaxel dose reduction due to toxicity ** Plinabulin + D

  13. Slide 13: Plinabulin + Docetaxel for NSCLC Phase 2 Data: Neutropenia

    Plinabulin + Docetaxel for NSCLC Phase 2 Data: Neutropenia Plinabulin ITT, cohorts 20 mg and 30 mg Cycle 1 Day 8 (Nadir) P < 0.0003* n=65 Grade 4/Severe neutropenia: ANC < 0.5 x 109 cells/L * docetaxel alone vs. Plinabulin + docetaxel n=39 n=47 12

  14. Slide 14: 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 35 30 25 20 15 10 5 0 -5 0 20 Grade 4 Neutropenia Blue: Docetaxel alone (N=73)Red: Docetaxel + Plinabulin (N=90) 40 60 80 100 120 Grade 3 Neutropenia Cycle 1 Cycle 2 Cycle 3 C

  15. Slide 15: The Lower the Nadir, the Longer the DSN

    The Lower the Nadir, the Longer the DSN There is a Correlation Between Nadir and Duration of Severe Neutropenia (DSN) Day 8 Neutropenia on Day 8 Grade 4 (severe) Neutropenia is ANC < 0.5 x 109 cells/L, normal levels are 2 x 109 < ANC < 5 x 109 cells/L Based on data published in the Sandoz - FDA Advi

  16. Slide 16: Estimated DSN Based on Nadir

    Estimated DSN Based on Nadir Day 8 Docetaxel Monotherapy Plinabulin + Docetaxel Mean DSN: 1.1 days Mean DSN: 0.065 days 0 1 2 3 4 Projected DSN 15

  17. Slide 17: Plinabulin Neutropenia Program: Two Studies

    Plinabulin Neutropenia Program: Two Studies INDICATION: We are currently conducting clinical trials of Plinabulin for concurrentadministration with a myelosuppressive chemotherapeutic regimen inpatients with non-myeloid malignancies for the prevention of chemotherapyinduced neutropenia. Study 105 De

  18. Slide 18: Study Design: Docetaxel

    Study 105 Design: Docetaxel Docetaxel in patients with NSCLC, breast cancer and prostate cancer Arm 1 Arm 2 Arm 3 Arm 4 Phase 2 Portion 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) Phase 3 Portion Neulasta 0.6 mg/m2 (n=77) Plinabulin 20 mg

  19. Slide 19: Study Design: TAC

    Study 106 Design: TAC Arm 1 Arm 2 Arm 3 Phase 2 Portion Neulasta 0.6 mg/m2 (n=20) Plinabulin 10 mg/m2 (n=20) Plinabulin 20 mg/m2 (n=20) Phase 3 Portion Neulasta 0.6 mg/m2 (n=60) Plinabulin 20 mg/m2 (n=60) *Current RP3D Statistics for Superiority in Phase 3 Portion Numeric Results for Testing the Dif

  20. Slide 20: Plinabulin Prevents Multiple Chemo's Neutropenia in Rat

    Plinabulin Prevents Multiple Chemo’s Neutropenia in Rat Neutropenia model Docetaxel Effect of Plinabulin on Docetaxel-Induced Neutropenia in Rat Blood 48 h. post Dosing (Docetaxel 1 h. prior to Plinabulin) p= 0.0355; n=5 per group 1.50 1.25 1.00 0.75 0.50 0.25 0.00 Cyclophosphamide Effect of Plinabu

  21. Slide 21: Plinabulin NDA Data Package

    Plinabulin NDA Data Package Plinabulin Compared to G-CSF Development Plan: • Indication for use: Prevention of chemotherapy induced neutropenia • Same primary efficacy: Duration of Severe Neutropenia (DSN) in Cycle 1 • Near identical clinical study designs • Similar sample sizes Clinical Data Summar

  22. Slide 22: Product Differentiation: Plinabulin vs. G-CSF

    Product Differentiation: Plinabulin vs. G-CSF Neutropenia Market $7.3 Billion Globally in 2015 Percentage of Patients Experiencing Grade 3 and 4 Neutropenia† Docetaxel 100 Neutropenia (n=49)* Docetaxel Docetaxel 100 75+ G-CSF (n=60)** (n=55)* Docetaxel Docetaxel 75 75 + Plinabulin(n=51)*** (n=81)***

  23. Slide 23: Plinabulin: Differentiated from G-CSF in Neutropenia Prevention

    Plinabulin: Differentiated from G-CSF in Neutropenia Prevention In 2015 Chemo-Induced Neutropenia was a $7.3 Billion Market G-CSF Bone pain in > 20% of patients Administered 24 hours after chemo G-CSF biologics/biosimilars mostlyused in the high risk FN segment and limited in use by side effects Pli

  24. Slide 24: Near Term Opportunity: Neutropenia Study

    Near Term Opportunity: Neutropenia Study 105 (Docetaxel) Phase 2/3 Q1 2017 H2 2017 H1 2018 H1 2019 Study Initiated First Data Readout Interim Analysis Final Readout Non-Inferiority Non-Inferiority Study 106 (TAC) Phase 2/3 H1 2017 H1 2018 H1 2019 Study Initiated First Data Readout Final Readout Supe

  25. Slide 25: NSCLC

    General Neutropenia Overview Prevention NSCLC BusinessHighlights Summary 24

  26. Slide 26: Plinabulin Anti-cancer MOA: Immune-Enhancing and Apoptosis

    Plinabulin Anti-cancer MOA: Immune-Enhancing and Apoptosis Cancer Cells Tumor Antigen Tumor Killing HMCII  RhoB .. Dendritic Cell CD80 Plinabulin Cancer CellApoptosis TubulinGEF-H1JNK-ActivationC-Jun Caspase-3 Activation CD86 o-Stimulation T-Cell Activation T-Cell TRIF-GEFH1-RhoB pathway is

  27. Slide 27: Phase 2 Anti-Cancer Activity Data Review: NSCLC

    Phase 2 Anti-Cancer Activity Data Review: NSCLC Encouraging Activity in Measurable Lung Lesion Oral Presentation at ASCO-SITC: Durable Response and Extended Survival Benefit of 4.6 Months Plinabulin Docetaxel + Docetaxel alone (DN) (D) N=38 N=38 11.3 M 6.7 M mOS P = 0.29 ORR 18.4% 10.5% 26

  28. Slide 28: NSCLC: Phase 3 Trial Design

    NSCLC: Phase 3 Trial Design Patient Criteria: • Patients with at least 1 measurable lung lesion • PD-1/PD-L1 antibody failures (stratified) • EGFR wild type, mutations not eligible; no restriction on histology • One prior platinum-based chemotherapy; no restriction on biological therapy • SAP Plan:

  29. Slide 29: Neutropenia Results in Phase 3 NSCLC Trial

    Neutropenia Results in Phase 3 NSCLC Trial Phase 3 NSCLC Trial Confirming Neutropenia Results on a Prospective Basis 28

  30. Slide 30: Clinical Program of Plinabulin in NSCLC

    Clinical Program of Plinabulin in NSCLC Efficacy Synergy of Plinabulin with Standard of Care Therapies Plinabulin+ Docetaxel* • PD-L1- in 2nd Line (50%) • PD-1/PD-L1 failed patients in 3rd line (80%) Phase 3: 550 patients to be enrolled Goal: Efficacy Synergy and Better Safety Plinabulin + PD-1 Anti

  31. Slide 31: NDA Plan for NSCLC

    NDA Plan for NSCLC Current Q1 2018 Q1 2019 550 patients to be Interim Analysis Final Analysis enrolled 30

  32. Slide 32: Business Highlights

    General Neutropenia Overview Prevention NSCLC BusinessHighlights Summary 31

  33. Slide 33: Uniquely Positioned to Access Large China Market

    Uniquely Positioned to Access to Large China Market Plinabulin is eligible for category 1 new drug approval in China, which will accelerate NDA review process and present the opportunity for early launch in China: • Innovative drug not approved elsewhere • Will manufacture in China for China market

  34. Slide 34: Financial Overview

    Financial Overview Utilizing existing and anticipated cash to pursue clinical developmentplan through 2017 • Continuance of Plinabulin + docetaxel Phase 3 for NSCLC • Completion of Plinabulin + nivolumab Phase 1/2 for NSCLC • Begin first registrational trial Plinabulin + chemo for prevention of neut

  35. Slide 35: Company Catalysts

    Company Catalysts 24-30 Months 6 Months P2 Data • Neutropenia 12-18 Months P3 Interim • Neutropenia • NSCLC Data • PD-1 ComboIND submission • BPI-002 [IO] P3 Final • Neutropenia • NSCLC IND submission • P3 PD-1 Combo • BPI-004 [IO] • Fred Hutchinson collaboration asset 34

  36. Slide 36: Summary

    General Neutropenia Overview Prevention NSCLC BusinessHighlights Summary 35

  37. Slide 37: Summary

    Summary Focused on developing novel therapies to treat multiple oncology indications Multiple near term catalysts for Plinabulin Efficient US / Chinaclinical development strategy Robust pipeline Strong management team • Multinational Phase 3 trial for NSCLC • Phase 2/3 trials for prevention of chemo

  38. Slide 38: Thank You!

    Thank You! Lan Huang, Ph.D. lhuang@beyondspringpharma.com BeyondSpring Inc. 28 Liberty Street, 39th Floor, New York, NY 10005 Tel: 646-305-6387 | Fax: 646-219-9660 37

  39. Slide 39: Addendum

    Addendum 38

  40. Slide 40: Additional Assets

    Additional Assets Fred Hutchinson Collaboration • Fred Hutchinson will provide up to six new projects per year for five yearsas potential ground-breaking cancer treatment or diagnostics options forlicense to BeyondSpring. • Ubiquitination Technology: One approach is using a “molecular glue” tobind u

  41. Slide 41: Robust Patent Estate

    Robust Patent Estate 72 grantedComposition and Usage Patents forPlinabulin in 34 countriesthrough 2025 5 additional US provisional global patent applications pending with the potentialfor protection to 2036 Composition of matter patent to 2025 (up to 2030 with possible patent term extension) 40

  42. Slide 42: Safety Data (Phase 2, NSCLC, Well Tolerated)

    Safety Data (Phase 2, NSCLC, Well Tolerated) Common (>=20%) AEs (% Grade 1-4;% Grade 3-4) 30 D (n=55） 30 DP (n=50） 20 D (n=18） 20 DP (n=40) Nausea 44;0 48;4 22;0 40;0 Fatigue 40;11 52;4 39;6 30;3 Diarrhea 33;4 58;8 33;11 35;5 Constipation 33;0 36;0 17;6 28;0 Anorexia 31;0 34;0 39;0 25;3 Pyrexia 29;2

  43. Slide 43: Study Design: Docetaxel

    Study 105 Design: Docetaxel Docetaxel in patients with NSCLC, breast cancer and prostate cancer Arm 1 Arm 2 Arm 3 Arm 4 Phase 2 Portion 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) Phase 3 Portion Neulasta 0.6 mg/m2 (n=77) Plinabulin 20 mg

  44. Slide 44: Plinabulin + Nivolumab for NSCLC

    Plinabulin + Nivolumab for NSCLC Pre-Clinical Animal studies provide indications of an immuneMOA, which primarily acts through activation andproliferation of tumor antigen-specific CD4 T-cells,a white blood cell active in immune responses. Combo of Plinabulin and PD-1 antibody in immunecompetent bre

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