Slide 1: Plinabulin DUBLIN-3 NSCLC Topline Data
Plinabulin DUBLIN-3 NSCLC Topline Data August 5 2021 | NASDAQ: BYSI
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 Note: 1 La Sala et al., 2019 Chem. 2 Kashyap et al., 2019 Cell Reports. 3 Zhang et al., 2005 Mol Cell Biol. 4 Singh et al., 2011 Blood. 5 Suwa et al., 2000 Am J Phy
Slide 4: Plinabulin Induces Dendritic Cell Maturation, a Key Step in Anti-cancer Durable Response
Plinabulin Induces Dendritic Cell Maturation (the most potent APC), a Key Step in Initiating Anti-cancer Durable Response ❶ + ❷ + ❸ Optimal Immuno-Oncology Response Release Tumor AntigensFor more potent anti-cancer effect ❶ Radiation/Chemotherapy/ Plinabulin Optimize T cell response ❸ Checkpoint I
Slide 5: Severely Unmet Medical Need – 2nd/3rd Line NSCLC, EGFR Wild Type
Severely Unmet Medical Need – 2nd/3rd Line NSCLC, EGFR Wild Type 1 Lancet Oncol. 2013 Sep;14(10):981-8. Large patient population with limited treatment optionsEGFR wild type: ~85% western NSCLC and ~70% of Asian NSCLC patients With immunotherapies moved to first line, Docetaxel-based therapies are t
Slide 6: Scientific Rationale – Patients with High GEF-H1 Live Longer
Scientific Rationale – Patients with High GEF-H1 Live Longer Patients with High GEF-H1 Immune Signature Live Longer in Various Cancers1 1 Kashyap et al., 2019 Cell Reports Based on Plinabulin’s Immune MOA, patients with measurable lung lesion were selected prospectively for Dublin-3 Study. Plinabuli
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) Non-squamous or squamous NSCLCStage IIIb/IVECOG performance status ≤ 2Progression during or after treatment with one or two treatment regimen containing platinumMust have at least on
Slide 8: Dublin-3 Phase 3 Topline Data – Significant Improvement in OS, PFS, ORR
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) Primary Endpoint Docetaxel (75 mg/m2)N=281 Plinabulin (30 mg/m2) + Docetaxel (75 mg/m2)N=278 OS (months or M) Mean OS,
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 patientsAnalysis 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 surviv
Slide 10: Product Profile (Plinabulin + Docetaxel for 2nd/3rd line NSCLC)
Product Profile (Plinabulin + Docetaxel for 2nd/3rd line NSCLC, EGFR wild type) Docetaxel (Current SOC) Modest survival benefit Severe safety concerns, e.g., CIN Poor Quality of Life Plinabulin - Docetaxel Combination Survival benefit, with longer survival due to GEF-H1 I/O MOA Favorable safety prof
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 Current Severe Unmet Medical Needs PD-1/PD-L1 resistant patients need later line therapies PD-1 + chemo double efficacy of PD-1,but with CIN risk PD-1 or PD-1+CTLA-4 with high ir
Slide 12: Plinabulin Franchise: Pipeline in a Drug
CIN (BTD & Priority Review)Superior Regimen vs. SOCPDUFA 11/30/2021 Multiple Cancers (I/O Combo)Synergistic MOA with Checkpoint Inhibitors & Promising Preclinical & Early Clinical Efficacy Data NSCLCStrong MOA Rationale & Successful DUBLIN-3 phase 3 Study Promising early clinical efficacy data – 7 d
Slide 13: www.beyondspringpharma.com
www.beyondspringpharma.com