Beyondspring, Inc. · NASDAQ:BYSI
Beyondspring — Investor Presentation (May 2017)
41 slides from Beyondspring's investor presentation, May 4, 2017
Slide 1: Transformational Science Advancing Oncology
Transformational Science Advancing Oncology
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 st
Slide 3: Agenda
Investment Highlights Neutropenia Prevention NSCLC Business Highlights Summary Agenda
Slide 4: BeyondSpring Inc. (BYSI) – NASDAQ IPO 3/9/2017
4 BeyondSpring Inc. (BYSI) – NASDAQ IPO 3/9/2017 IPO & Concurrent Private Placement: $54.3 M Investors: HuaRong , $150 B fund, Largest Asset Management Co. in China; Sangel , top 10 Biotech Focused Fund in China; Fosun , $70 B Investment Conglomerate.
Slide 5: Investment Highlights
5 Investment Highlights Plinabulin （ Phase 3 Late Stage ） • New IO Target GEF - H1, New Chemical Structure ； • Strong Patent Portfolio: Patent Granted in 34 countries Efficient Model • One global trial to achieve potential approval in two of the largest pharmaceutical markets in the world: US and Ch
Slide 6: Seasoned Leadership Team – Brought drugs to Market
6 Seasoned Leadership Team – Brought 30 drugs to Market Lan Huang, PhD: Co - Founder, Chairman & Chief Executive Officer • Co - 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 Phar
Slide 7: Pipeline Overview
7 Plinabulin Preclinical Phase 1 Phase 2 Phase 3 Status Prevention of Neutropenia (in chemo induced Neutropenia) Study 105 (docetaxel) IND Initiation 1Q 2017 First Data Readout : 2H 2017 Study 106 (TAC) First Data Readout: 1H 2018 NSCLC: Measurable lung tumor (+ D ocetaxel ) Initiation 2Q 2016 Reado
Slide 8: Agenda: Investment Highlights
8 Investment Highlights Neutropenia Prevention NSCLC Business Highlights Summary
Slide 9: Plinabulin's New IO Target: GEF-H1
9 Plinabulin Dendritic Cell Neutropenia Prevention Effects Plinabulin’s New IO Target: GEF - H1 JNK Activation Rho Activation Immune – Related Anticancer Effects Plinabulin Kashyap A et al. Keystone Meeting ， Mar. 2017 Wang Y et al. FEBS J. 2016; 283: 102 - 111 300 derivatives
Slide 10: Plinabulin + Docetaxel in NSCLC: Phase 1/2 Trial
10 Patients included: 2 nd /3 rd line NSCLC, stage 3b/4 n=163 Docetaxel 75mg/m 2 n=55 Docetaxel 75mg/m 2 + Plinabulin 30mg/m 2 n=50 Docetaxel 75mg/m 2 n=18 Docetaxel 75mg/m 2 + Plinabulin 20mg/m 2 n=40 Cohort 1: 30mg/m 2 Cohort 2: 20mg/m 2 Endpoints: • Primary: Overall Survival (OS) • Safety (includ
Slide 11: Severe Neutropenia after Docetaxel Monotherapy
11 Severe Neutropenia after Docetaxel Monotherapy Source: Quartino et al Invest New Drugs 2012; 30:833 - 845 • Severe Infections • Sepsis • Hospitalizations • High Mortality Cycle 1 DAYS Day 8
Slide 12: Phase 2 Data Presented at ASH Meeting (Dec. 2016)
12 Phase 2 Data: Presented at ASH Meeting (Dec. 2016) 20162016 Data of Phase 2 Plinabulin ITT, cohorts 20 mg and 30 mg with lab values x Effect of Plinabulin dose on cycle 1 day 8 Plinabulin 20 mg/m 2 vs Docetaxel: p - value < 0.0001 Plinabulin 30 mg/m 2 vs Docetaxel: p - value < 0.0001 Plinabulin 2
Slide 13: Plinabulin Significantly Reduces Severe Neutropenia of Docetaxel
13 Plinabulin Significantly Reduces Severe Neutropenia of Docetaxel Grade 4/ Severe Neutropenia : ANC < 0.5 x 10 9 cells/L * Plinabulin + Docetaxel vs. Docetaxel P < 0.0003* Phase 2 Data ： Cycle 1 Day 8 ( Neutrophil NADIR ) n=65 Docetaxel n=39 Docetaxel + Plinabulin 20mg/m2 n=47 Docetaxel + Plinabul
Slide 14: Estimated DSN Based on Nadir Day
14 Estimated DSN Based on Nadir Day 8 Mean DSN: 1.1 days Docetaxel Monotherapy 0 1 2 3 4 Mean DSN: 0.065 days Plinabulin + Docetaxel Projected DSN
Slide 15: Product Differentiation: Plinabulin vs. G-CSF
15 Product Differentiation: Plinabulin vs. G - CSF Percentage of Patients Experiencing Grade 3 and 4 Neutropenia † Neutropenia Docetaxel 100 (n=49)* Docetaxel 100 + G - CSF (n=60)** Docetaxel 75 (n=55)* Docetaxel 75 (n=51)*** Docetaxel 75 + Plinabulin (n=81)*** Grade 3/4 85.7% 41% 67.3% 66.7% 11.5%
Slide 16: Plinabulin Prevents Multiple Chemo's Neutropenia in Rat
16 Docetaxel C o n t r o l C y c l o p h o s p h a m i d e 1 2 . 5 m g / k g i p P l i n a b u l i n 7 . 5 m g / k g i p P l i n a b u l i n + C y c l o p h o s p h a m i d e 0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 Effect of Plinabulin on Cyclophosphamide-Induced Neutropenia in R
Slide 17: Plinabulin Neutropenia Program: Two Studies
17 Plinabulin Neutropenia Program: Two Studies Study 105 Design : Non - Inferiority (Docetaxel) Study Protocol Title (BPI - 2358 - 105 ) : A Phase 2 / 3 , Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia (DSN) with Plinabulin Versus Pegfilgrastim in Patients wi
Slide 18: Study 105 Design: Docetaxel
18 Study 105 Design: Docetaxel Neulasta 0.6 mg/m 2 (n=10) Plinabulin 5 mg/m 2 (n=10) Plinabulin 10 mg/m 2 (n=10) Plinabulin 20 mg/m 2 (n=10) Arm 1 Arm 2 Arm 3 Arm 4 Phase 2 Portion Phase 3 Portion Interim Analysis at n=50/Arm Primary Endpoint: DSN in Cycle 1 N on - Inferiority Margin: 0.65 days
Slide 19: Study 106 Design: TAC
19 Neulasta 0.6 mg/m 2 (n=20) Plinabulin 10 mg/m 2 (n=20) Plinabulin 20 mg/m 2 (n=20) Arm 1 Arm 2 Arm 3 Phase 2 Portion Phase 3 Portion Final Analysis at n=60/Arm Sequential Analysis (DSN cycle 1) Non - Inferiority Superiority Neulasta 0.6 mg/m 2 (n=60) Plinabulin 20 mg/m 2 (n=60) *Current RP3D
Slide 20: Plinabulin Compared to G-CSF Development Plan
20 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 Summary Section : • BPI -
Slide 21: Plinabulin: Differentiated from G-CSF in Neutropenia Prevention
21 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 mostly used in the high risk FN segment and limited in use by side
Slide 22: Near Term Opportunity: Neutropenia
22 Near Term Opportunity: Neutropenia Q1 2017 Study Initiated H2 2017 First Data Readout H1 2018 Interim Analysis Non - Inferiority H1 2019 Final Readout Non - Inferiority H1 2017 Study Initiated H1 2018 First Data Readout H1 2019 Final Readout Superiority Study 105 (Docetaxel) Phase 2/3 Study 106 (
Slide 23: Agenda: General Overview
23 General Overview Neutropenia Prevention NSCLC Business Highlights Summary
Slide 24: Phase 2 Data: Oral Presentation at ASCO-SITC Meeting
24 Phase 2 Data: Oral Presentation at ASCO - SITC Meeting (Feb.2017) Plinabulin + Docetaxel (DN) Docetaxel (D) N =38 N=38 mOS 11.3 M 6.7 M P = 0.29 ORR 18.4% 10.5% Durable Response and Extended Survival Benefit of 4.6 Months
Slide 25: Docetaxel + Plinabulin NSCLC: Phase 3 Trial Design
25 Docetaxel + Plinabulin 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
Slide 26: Ongoing Global Phase 3 NSCLC Trial
26 PI for China Dr. Yan Sun: Trained at MD Anderson, lead investigator for Phase 3 trials of approved lung cancer drugs. China contributes 80% of 550 patients. CRO for global trial ICON : same CRO for Afatinib, phase 3 trial with 72% data from China Ongoing Global Phase 3 NSCLC Trial Plinabulin ： EG
Slide 27: Neutropenia Results in Phase 3 NSCLC Trial
27 Neutropenia Results in Phase 3 NSCLC Trial Phase 3 NSCLC Trial Confirming Neutropenia Results on a Prospective Basis
Slide 28: Plinabulin + Nivolumab for NSCLC
28 Plinabulin + Nivolumab for NSCLC Animal studies provide indications of an immune MOA, which primarily acts through activation and proliferation of tumor antigen - specific CD 4 T - cells, a white blood cell active in immune responses . Combo of Plinabulin and PD - 1 antibody in immune competent b
Slide 29: Clinical Program of Plinabulin in NSCLC
29 Clinical Program of Plinabulin in NSCLC Efficacy Synergy of Plinabulin with Standard of Care Therapies Plinabulin + Docetaxel* • PD - L1 - in 2 nd Line (50%) • PD - 1/PD - L1 failed patients in 3 rd line (80%) Phase 3: 550 patients to be enrolled Goal: Efficacy Synergy and Better Safety Plinabuli
Slide 30: NDA Plan for NSCLC (Plinabulin + Docetaxel)
30 NDA Plan for NSCLC (Plinabulin + Docetaxel) Current 550 patients to be enrolled Q1 2018 Interim Analysis Q1 2019 Final Analysis
Slide 31: Agenda: Business Highlights
31 Investment Highlights Neutropenia Prevention NSCLC Business Highlights Summary
Slide 32: Uniquely Positioned to Access Large China Market
32 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 mar
Slide 33: Financial Overview
33 Financial Overview Utilizing existing cash and IPO proceeds to pursue clinical development plan through 2019 • Completion of Plinabulin + docetaxel Phase 3 for NSCLC • Completion of two Phase 2/3 trials Plinabulin + chemo for prevention of neutropenia • Completion of two Plinabulin + nivolumab Ph
Slide 34: Agenda: Summary
34 Investment Highlights Neutropenia Prevention NSCLC Business Highlights Summary
Slide 35: Company Catalysts
35 Company Catalysts 6 Months 12 - 18 Months 24 - 30 Months P3 Final • Neutropenia • NSCLC IND submission • P3 PD - 1 Combo • BPI - 004 [IO] • Fred Hutchinson collaboration asset P3 Interim • Neutropenia • NSCLC Data • PD - 1 Combo IND submission • BPI - 002 [IO] P2 Data • Neutropenia
Slide 36: Thank You!
36 Thank You! Contact: Lan Huang, Ph.D. [email protected] BeyondSpring Inc. 28 Liberty Street, 39 th Floor, New York, NY 10005 Tel : 646 - 305 - 6387 | Fax : 646 - 219 - 9660
Slide 37: Addendum
37 Addendum
Slide 38: Additional Assets
38 Additional Assets • Fred Hutchinson will provide up to six new projects per year for five years as potential ground - breaking cancer treatment or diagnostics options for license to BeyondSpring. • Ubiquitination Technology: One approach is using a “molecular glue” to bind ubiquitin ligase to the
Slide 39: Robust Patent Estate
39 Robust Patent Estate ▪ 72 granted Composition and Usage Patents for Plinabulin in 34 countries through 2025 ▪ 5 additional US provisional global patent applications pending with the potential for protection to 2036 ▪ Composition of matter patent to 2025 (up to 2030 with possible patent term exten
Slide 40: Safety Data (Phase 2, NSCLC, Well Tolerated)
40 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 30;0 17;0 23;0 Vomiting 22;0 34;4 33;6 35;0 Cough 33;0 22;0 28;0 33;0 Alopecia 29;0
Slide 41: Study 105 Design: Non-Inferiority Statistics
41 Study 105 Design: Docetaxel Neulasta 0.6 mg/m 2 (n=10) Plinabulin 5 mg/m 2 (n=10) Plinabulin 10 mg/m 2 (n=10) Plinabulin 20 mg/m 2 (n=10) Arm 1 Arm 2 Arm 3 Arm 4 Phase 2 Portion Phase 3 Portion Interim Analysis at n=50/Arm Non - Inferiority margin 0.65 days Primary Endpoint: DSN in cycle 1 Plin