Beyondspring, Inc. · NASDAQ:BYSI
Beyondspring — Investor Presentation (April 2022)
45 slides from Beyondspring's investor presentation, April 2022
Slide 1: Corporate Presentation
Corporate Presentation APRIL 2022| 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: BeyondSpring Investment Highlights
BeyondSpring Investment Highlights (Nasdaq: BYSI) Headquarters New York, NY Committed to raising the standard of care Lead Asset Plinabulin, first-in-class, Selective Immunomodulating for cancer patients with first-in-class Microtubule-Binding Agent (SIMBA) treatments that improve lives and clinical
Slide 4: Robust Plinabulin Pipeline: Near-Term NDAs & I/O Clinical Trials
Robust Plinabulin Pipeline: 2 Near-Term NDAs & I/O Clinical Trials Indication / Trial Name / Commercial Program Preclinical Phase 1 Phase 2 Phase 3 Target Collaborator Rights1 NSCLC Plinabulin + docetaxel DUBLIN-3 Ph. 3 primary and secondary endpoints presented at ESMO ’21 Global (2nd/3rd line) Late
Slide 5: Plinabulin Franchise
Plinabulin Franchise Clinical Confirmation Expand Transform Promising early clinical efficacy data Positive topline phase 3 OS data (n=559) – 7 different cancers in phase 1/2 study Confirmed in 6 clinical studies (n>1200) & Accepted for NDA review CIN (BTD & Priority Review) NSCLC Multiple Cancers (
Slide 6: Plinabulin: Pipeline in a Drug Potential
Plinabulin: “Pipeline in a Drug” Potential - First-in-Class, Selective Immunomodulating Microtubule-Binding Agent (SIMBA) 6
Slide 7: Novel Mechanism of Action
Novel Mechanism of Action Plinabulin: First-in-Class, Selective Immunomodulating Microtubule-Binding Agent (SIMBA) - Plinabulin Induces Dendritic Cell Maturation (the most potent APC), a Key Step in Initiating Anti-Cancer Durable Response ❷ Plinabulin Stimulate maturation of dendritic cells to incre
Slide 8: Plinabulin Clinical Program Overview
Over 700 Patients Treated with Plinabulin to date in Clinical Program; NB SS DI CIN Prevention benefit shown in 6 trials A Q Study 101 Phase 1/2 Phase 2 Efficacy Data Phase 2 Phase 3 Registration Anti- Cancer Study 103 (DUBLIN-3, n=559) 4.6 month mOS Plinabulin + Docetaxel vs. Plinabulin + extension
Slide 9: Plinabulin Opportunity
Plinabulin Opportunity 1 Plinabulin is a novel mechanism, first-in-class immunomodulating microtubule-binding agent, complementary to existing standard of care 2 Near-term NDA and revenue opportunity in China for Chemotherapy Induced Neutropenia (CIN) Prevention, with commercial partner Hengrui 3 DU
Slide 10: Delivering the Plinabulin Value Proposition
Delivering the Plinabulin Value Proposition Near Term Opportunity Longer-Term Potential CIN Prevention ANTI-CANCER Raise the Standard of Care w/ Immuno-Oncology Potential NSCLC APC Cornerstone of Improve Survival and emerging regimens Quality of Life 10
Slide 11: Chemotherapy-induced Neutropenia (CIN) Prevention Indication
Chemotherapy-induced Neutropenia (CIN) Prevention Indication 11
Slide 12: Unmet Medical Need in Week 1 After Chemotherapy
CIN Unmet Medical Need in Week 1 After Chemotherapy Despite widespread G-CSF use, CIN is #1 reason for FN, ER visits, hospitalization, sepsis, mortality, and chemotherapy dose reduction and disruption 1 Short-term Long-term G-CSF is more effective in week 2 after Chemotherapy’s anti-cancer chemo in
Slide 13: Chemotherapy Without Compromise: Turning the Ds into the 4 Ss
CIN Chemotherapy Without Compromise: Turning the 4 Ds into the 4 Ss DECREASED STABLE DOSE recommended dose maintaining >85% Plinabulin + G-CSF DELAYED cycles SUSTAINED CYCLES cycles on time • Differentiated clinical profile, potential to improve SOC DISCONTINUED chemotherapy STAY THE COURSE complete
Slide 14: Plinabulin + G-CSF Combination Addresses Unmet Medical Need
CIN Plinabulin + G-CSF Combination Addresses Unmet Medical Need Plinabulin is the only product in development that has demonstrated the potential to elevate the standard of care (SOC) to prevent CIN 7.0 Pegfilgrastim 6 mg (n=22) • Breakthrough Therapy Designation: Unmet Plinabulin 20 mg/m2 + Pegfilg
Slide 15: Protective-2 Ph 3: Registration Study Design
CIN Protective-2 (Study 106) Ph 3: Registration Study Design • Double blind, global study (19 centers); 4 cycles • Covance: CRO • Covance Central Lab: ANC evaluation Plinabulin 40mg + Pegfilgrastim 6 mg N=111 Breast Cancer, R 1:1 TAC Therapy Placebo + Pegfilgrastim 6 mg N=110 15
Slide 16: PROTECTIVE-2 Phase 3: Primary Endpoint Met
CIN PROTECTIVE-2 Phase 3: Primary Endpoint Met Proportion of Patients with NO Grade 4 Neutropenia (or DSN= 0 Days) in Cycle 1 35.0% Global 31.5% China 30.0% （p=0.0015） （p=0.0015） 24.1% 25.0% DSN=0 20.0% 13.6% N=111 15.0% 全球 N=110 N=58 10.0% N=110 3.5% 5.0% N=57 0.0% Pegfilgrastim Plinabulin 40 mg +
Slide 17: Favorable Benefit/Risk Ratio
CIN Favorable Benefit/Risk Ratio (Plinabulin + G-CSF vs. G-CSF alone) Improved Efficacy (ANC based Improved Efficacy (FN) Favorable Safety in Cycle 1) – 106 Phase 3 – 106 Phase 3 – 106 Phase 2+3 No Grade 4 Neutropenia FN Grade 4 TEAE (primary endpoint) • 3.6% vs. 6.3% (incidence) • 20% less Grade 4
Slide 18: China NMPA Review Ongoing; Discuss Regulatory Pathway with U.S. FDA
CIN China NMPA Review Ongoing; Discuss Regulatory Pathway with U.S. FDA Seeking Approval for “Plinabulin + G-CSF Combination” in CIN Prevention Registration Study Supporting Studies Supporting Studies Plinabulin + G-CSF combo Plinabulin vs. placebo vs. G-CSF mono Plinabulin vs. G-CSF (Dublin-3, phas
Slide 19: Plinabulin Has Potential Use Across the Spectrum of Solid Tumors
CIN Plinabulin Has Potential Use Across the Spectrum of Solid Tumors G-CSF Administrations: Solid Tumor Rectal Cancer Gynecological 5% Cancer, Other G-CSF Use by Cancer type: Ovarian 5% Cancer • Improved control of CIN with 5% Plinabulin can prove important in Prostate Cancer cancers with more aggre
Slide 20: Potential to Elevate Standard of Care for CIN Prevention
CIN Potential to Elevate Standard of Care for CIN Prevention Opportunity Unmet need Product differentiation ✓Market size ✓Grade 4 neutropenia complications Plinabulin + G-CSF addresses 3 oncologist ✓Market growth ✓CIN: #1 reason for therapy change needs: ✓NCCN guideline change (4Ds) ✓ Keeps ANC out
Slide 21: 2nd/3rd line NSCLC Indication
2nd/3rd line NSCLC Indication 21
Slide 22: Severe Unmet Medical Needs – 2nd/3rd Line NSCLC, EGFR Wild Type
Anti-Cancer Severe Unmet Medical Needs – 2nd/3rd Line NSCLC, EGFR Wild Type • Large patient population with limited treatment Efficacy 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 ma
Slide 23: Underserved Market: 2nd/3rd Line NSCLC Treatment
Anti-Cancer Underserved Market: 2nd/3rd Line NSCLC Treatment With PD-1/PD-L1 Moved To First Line, Patients are Left with Efficacy and Safety Tradeoffs and Suboptimal Regimens Treatment Ramuciramab + Docetaxel vs. Docetaxel1 Pemetrexed vs Docetaxel2 Low CIN risk Pros Limited efficacy; OS HR: 0.86 (se
Slide 24: DUBLIN-3: Docetaxel + Plinabulin vs. Docetaxel + Placebo
Anti-Cancer DUBLIN-3: Docetaxel + Plinabulin (DP) vs. Docetaxel + Placebo (D) in Patients With 2nd/3rd line NSCLC, EGFR wild type Global, Randomized, Single-Blinded (blinding for patients only) Stratified for: Region (Asia/non-Asia), Prior Line, ECOG score Around 60 sites: U.S., China, and Australia
Slide 25: Met Primary Objective in Overall Survival (OS)
Anti-Cancer Met Primary Objective in Overall Survival (OS) HR = 0.82 25
Slide 26: Significantly Increase Long-term OS Rate
Anti-Cancer Significantly Increase Long-term OS Rate 26
Slide 27: Significant Improvement in PFS, Double ORR
Anti-Cancer Significant Improvement in PFS, Double ORR HR = 0.76 Log rank P = 0.0082 27
Slide 28: Significant Reduction in Grade 4 Neutropenia
Anti-Cancer Significant Reduction in Grade 4 Neutropenia Cycle 1 Day 8 and All Cycles Day 8 Grade 4 neutropenia, Cycle 1 Day 8 Grade 4 neutropenia, All Cycles Day 8 100% 100% 90% 90% P<0.0001 P<0.0001 Percentage of Patients Percentage of Patients 80% 80% 70% 70% 60% 60% 50% 50% 40% 40% 33.58% 30% 27
Slide 29: Significant Improve Quality of Life Benefit - Q-TWiST
Anti-Cancer Significant Improve Quality of Life Benefit - Q-TWiST (Quality-Adjusted Time Without Symptoms of Disease and Toxicity) Plinabulin + Docetaxel Docetaxel alone Clinically Meaningful Improvement of >18% in Q-TWiST. 29
Slide 30: Dublin-3: Superior Efficacy and Significant Reduction in Grade 4 CIN
Anti-Cancer Dublin-3: Superior Efficacy and Significant Reduction in Grade 4 CIN (DP vs. D) Plinabulin (30 mg/m2) Docetaxel (75 mg/m2) Primary Endpoint + Docetaxel (75 mg/m2) N=281 N=278 OS (months or M) Mean 12.77 M (0.676) Mean 15.08 M (0.848); p=0.03 Median 10.5 M (9.3, 11.9), Log-rank p=0.0399 M
Slide 31: IO Combinations
BeyondSpring 10 Combinations
Slide 32: Plinabulin as Potential Cornerstone Add-on Therapy to Current I/O Regimens
Plinabulin as Potential Cornerstone Add-on Therapy to Current I/O I/O Regimens to Address Severe Unmet Medical Needs PD-1/PD-L1 Inhibitors Potential to greatly expand - $30B global annual sales the addressable market Current Severe Unmet Medical Needs Plinabulin Clinical Development • PD-1/PD-L1 res
Slide 33: Plinabulin in Triple Combo Development for Multiple Cancer Indications
Plinabulin in Triple Combo Development for Multiple Cancer Indications I/O in PD-1/PD-L1 Failed Patients Trial Name / Status Indication / Target Program Commercial Rights Collaborator SCLC Plinabulin + 7 US sites, including Phase 1 completed, Checkpoint naïve and Nivolumab (PD-1) + Rutgers Universit
Slide 34: Efficacy Analysis (Phase I) Plinabulin + Nivolumab + Ipilimumab in SCLC
I/O Efficacy Analysis (Phase I) Plinabulin + Nivolumab + Ipilimumab in SCLC PD-1/PD-L1 PD-1/PD-L1 resistant Efficacy Analysis therapy naïve (n=7) (n= 6) Number of 3 (50%) 3 (43%) patients with PR *PR –Partial Response - RESIST 1.1 : At least a 30% decrease in the sum of diameters of target lesions,
Slide 35: Plinabulin as a Potential Synergistic Cornerstone Agent in I/O Therapy
I/O Plinabulin as a Potential Synergistic Cornerstone Agent in I/O Therapy Data Conclusion • High response rate to previous CPI • Immune system re-sensitized failures (43%) • Improved Anti-cancer Response • Increased antigen presentation (46% ORR vs. 12-23% CPI) simulates T cell activation • Durable
Slide 36: Commercial Plan in China
* BeyondSpring Commercial Plan in China
Slide 37: Commercial Potential in CIN Prevention Market in China
Commercial Potential in CIN Prevention Market in China G-CSF product annual sales in China (¥100,000,000) Overview of marketed long-acting G-CSF products in China2 Product Company Approval Date +30% 803 Jinyouli 28 Short-lasting G-CSF CSPC 2012 (津优力) 501 Xinruibai 381 Qilu 2015 20 (新瑞白) 291 52 21 Ai
Slide 38: Rapid Growth in China's NSCLC Market
Rapid Growth in China’s NSCLC market NSCLC drug sales in China1 (¥100,000,000 or $15.7 M USD) 52 17 30 17 7 ⚫ Between 2015 and 2019, the number of new cases of NSCLC in China increased from 669,000 to 761,000, and the number of new cases is expected to reach over 1 million by 20301. ⚫ NSCLC drugs sa
Slide 39: Hengrui is the Ideal Partner for Plinabulin in Greater China
Hengrui is the Ideal Partner for Plinabulin in Greater China Exceptional synergy between plinabulin and Hengrui pipeline ➢ Hengrui is the leader in oncology product R&D and commercialization in China • Established in 1970; Listed on Shanghai Stock Exchange in 2000 (Shanghai stock exchange ticker: 60
Slide 40: Hengrui Partnership Supports Key Commercialization Goals in China
Hengrui Partnership Supports Key Commercialization Goals in China Manages commercialization risk and optimizes return on plinabulin franchise • Leverages existing infrastructure of leading oncology player • Minimizes launch investment and risk • Optimizes near-term return through performance-related
Slide 41: Corporate Highlights
BeyondSpring Corporate Highlights
Slide 42: Plinabulin: Hengrui and Wanchunbulin Partnership in Greater China
Plinabulin: Hengrui and Wanchunbulin Partnership in Greater China (BeyondSpring Inc. owns 58% of Wanchunbulin) Hengrui is the oncology leader in China, with great synergies with Plinabulin - Manages commercialization risk and optimizes return on plinabulin franchise Hengrui: Plinabulin Rights in Gre
Slide 43: SEED Therapeutics Subsidiary – Pipeline Potential
SEED Therapeutics Subsidiary – Pipeline Potential SEED: Subsidiary pursuing "Molecular Glue" targeted protein degradation to degrade disease-causing proteins previously believed to be undruggable • $800M collaboration with Eli Lilly on three targets • Own targets (e.g., KRAS) • Structure conducive t
Slide 44: BeyondSpring: Key Highlights
BeyondSpring: Key Highlights Committed to raising the standard of care for cancer with first-in-class treatments that improve lives and Mission clinical outcomes for millions of patients in need Near-term Global Capabilities Broad Pipeline Global Market Opportunities Continuous Innovation Plinabulin
Slide 45: www.beyondspringpharma.com
www.beyondspringpharma.com 45