Beyondspring, Inc. · NASDAQ:BYSI
Beyondspring — Technical Presentation (August 2021)
13 slides from Beyondspring's technical presentation, Aug 5, 2021
Slide 1: Plinabulin DUBLIN-3 NSCLC Topline Data
Plinabulin DUBLIN-3 NSCLC Topline Data August 5 2021 | NASDAQ: BYSI 1
Slide 2: Disclaimer
Disclaimer This presentation has been prepared for informational purposes only. No money or other consideration is being solicited, and if sent in response, will not be accepted. This presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shal
Slide 3: Plinabulin: First-in-Class Selective Immunomodulating Microtubule-Binding Agent (SIMBA)
Plinabulin: First-in-Class, Selective Immunomodulating Microtubule- Binding Agent (SIMBA) - Potent Antigen Presenting Cell (APC) inducer GEF-H1 activation2 1 Plinabulin Rho/ROCK activation1 Microtubules Neutrophil demargination7 Kill cancer cells4 JNK activation2 Dendritic cell maturation2,3 Kill ca
Slide 4: Plinabulin Induces Dendritic Cell Maturation, a Key Step in Initiating Anti-cancer Durable Response
Plinabulin Induces Dendritic Cell Maturation (the most potent APC), a Key Step in Initiating Anti-cancer Durable Response ❷ Plinabulin 2 3 ❸ Checkpoint Inhibitors Stimulate maturation of dendritic Optimize T cell response cells to increase antigen presentation Dendritic cells are the most important
Slide 5: Severely Unmet Medical Need – 2nd/3rd Line NSCLC, EGFR Wild Type
Severely Unmet Medical Need – 2nd/3rd Line NSCLC, EGFR Wild Type • Large patient population with limited Efficacy treatment options o EGFR wild type: ~85% western NSCLC and ~70% of Asian NSCLC patients Safety o With immunotherapies moved to first line, Docetaxel-based therapies are the mainstay ther
Slide 6: Scientific Rationale – Patients with High GEF-H1 Live Longer
Scientific Rationale – Patients with High GEF-H1 Live Longer Plinabulin Activates GEF-H11 Patients with High GEF-H1 Immune Signature Live Longer in Various Cancers1 Based on Plinabulin’s Immune MOA, patients with measurable lung lesion were selected prospectively for Dublin-3 Study. 1 Kashyap et al.
Slide 7: Docetaxel + Plinabulin vs Docetaxel + Placebo in 2nd/3rd Line NSCLC (DUBLIN-3)
Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With 2nd/3rd line NSCLC, EGFR wild type (DUBLIN-3) Global, Randomized, Single-Blinded (blinding for patients only) Stratified for: Region (Asia/non-Asia), Prior Line, ECOG score 60 sites: U.S., China, and Australia Docetaxel + • Non-
Slide 8: Dublin-3 Phase 3 Topline Data
Dublin-3 Phase 3 Topline Data - Significant Improvement in OS, PFS, ORR, 24 M, 36 M OS Rate (Combo vs. Docetaxel) - Significant Reduction in Grade 4 Neutropenia (Combo vs. Docetaxel) Plinabulin (30 mg/m2) Docetaxel (75 mg/m2) + Docetaxel (75 mg/m2) Primary Endpoint N=281 N=278 Mean OS, p=0.03 OS (mo
Slide 9: OS Analysis Method Based on Relevance
OS Analysis Method Based on Relevance 1. Mean OS p value – Most Relevant for immune agent with more longer survival patients - Analysis method stated in Statistical Analysis Plan (SAP); the data will be included in Clinical Study Report (CSR) Mean OS takes into consideration all patients’ overall su
Slide 10: Product Profile (Plinabulin + Docetaxel for 2nd/3rd line NSCLC, EGFR wild type)
Product Profile (Plinabulin + Docetaxel for 2nd/3rd line NSCLC, EGFR wild type) Next steps: Discuss filing plan with FDA & NMPA in 2021 with potential filing 1H 2022 Docetaxel (Current SOC) Plinabulin - Docetaxel Combination • Survival benefit, with longer survival • Modest survival benefit due to G
Slide 11: Plinabulin: Potential as the Cornerstone Therapy to Add onto Current IO Therapies
Plinabulin: potential as the “Cornerstone” Therapy to Add onto Current IO Therapies to Address Severe Unmet Medical Needs PD-1/PD-L1 Inhibitors Potential to greatly expand - $30 B global annual sales the addressable market Current Severe Unmet Medical Needs Plinabulin Clinical Development • PD-1/PD-
Slide 12: Plinabulin Franchise: Pipeline in a Drug
Plinabulin Franchise: Pipeline in a Drug Clinical Confirmation Expand Transform Promising early clinical efficacy data Positive Phase 3 Topline OS data (n=559) – 7 different cancers in phase 1/2 study & potential NDA filing 1H 2022 Confirmed in 6 clinical studies (n>1200) & Filed for NDA approval CI
Slide 13: www.beyondspringpharma.com
www.beyondspringpharma.com 13