Beyondspring, Inc. · NASDAQ:BYSI
Beyondspring — Investor Presentation (October 2021)
51 slides from Beyondspring's investor presentation, October 2021
Slide 1: Corporate Presentation
Corporate Presentation October 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: BeyondSpring Investment Highlights
BeyondSpring Investment Highlights (Nasdaq: BYSI) Headquarters New York, NY Plinabulin for CIN, US NDA PDUFA November 30, 2021 Committed to raising the standard Lead Asset Plinabulin for NSCLC, est. NDA filing 1H 2022 of care for cancer patients with first- in-class treatments that improve Partnersh
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 Status/Next Milestone Target Collaborator Rights1 • Positive topline Phase 3 data August 2021 NSCLC Phase 3 primary and secondary endpoints met in pivot
Slide 5: Plinabulin Franchise: "Pipeline in a Drug"
Plinabulin Franchise: “Pipeline in a Drug” Clinical Confirmation Expand Transform Promising early clinical efficacy data Positive Phase 3 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 CIN (BTD
Slide 6: Plinabulin: First-in-Class, Selective Immunomodulating Microtubule-Binding Agent
Plinabulin: “Pipeline in a Drug” - 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: Triple I/O Combo: Plinabulin + PD-1 + Radiation
Triple I/O Combo: Plinabulin + PD-1 + Radiation (IR) Best Tumor Response in PD-1 Non-Responsive Tumor Model (MD Anderson) Tumor Volume (mm3) 2000 1000 0 DC activation is most dramatic in triple T cell doubles in triple I/O Combination I/O combination vs. PD1 + IR Biomarker data in tumor 30 days afte
Slide 9: Plinabulin Clinical Development Program
Plinabulin Clinical Development Program NB SS DI A Q Study 101 Phase 1/2 Phase 2 Efficacy Data Phase 2 Phase 3 Registration Study 103 (DUBLIN-3, n=559) Anti- Cancer 4.6 month mOS Plinabulin + Docetaxel vs. Plinabulin + extension Docetaxel in 2nd/3rd NSCLC, EGFR docetaxel vs. docetaxel in Plinabulin
Slide 10: Plinabulin Opportunity
Plinabulin Opportunity 1 Plinabulin is a novel mechanism, first-in-class immunomodulating microtubule-binding agent, complementary to existing standard of care 2 DUBLIN-3 provides compelling clinical data in 2L/3L NSCLC; potential to move into earlier lines of therapy and into broad range of tumor t
Slide 11: Delivering the Plinabulin Value Proposition
Delivering the Plinabulin Value Proposition Near Term Opportunity Longer-Term Potential ANTI-CANCER w/ Chemotherapy Improve Survival and ANTI-CANCER Quality of Life w/ Immuno-Oncology Potential APC Cornerstone of CIN emerging regimens Raise the Standard of Care 11
Slide 12: Anti-Cancer with Chemotherapy
Anti-Cancer with Chemotherapy 12
Slide 13: NSCLC: Severe Unmet Medical Needs – 2nd/3rd Line, EGFR Wild Type
Anti-Cancer NSCLC: Severe Unmet Medical Needs – 2nd/3rd Line, 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 m
Slide 14: 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 15: NSCLC: Scientific Rationale – Patients with High GEF-H1 Live Longer
Anti-Cancer NSCLC: 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 Stud
Slide 16: NSCLC DUBLIN-3: Docetaxel + Plinabulin vs. Docetaxel + Placebo
Anti-Cancer NSCLC DUBLIN-3: Docetaxel + Plinabulin vs. Docetaxel + Placebo in Patients With 2nd/3rd line, 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 Docetaxe
Slide 17: Met Primary Objective in Overall Survival (OS)
Anti-Cancer Met Primary Objective in Overall Survival (OS) HR = 0.82 17
Slide 18: Met Primary Objective in Overall Survival (OS)
Anti-Cancer Met Primary Objective in Overall Survival (OS) 18
Slide 19: Significant Improvement in PFS, Double ORR with Plinabulin
Anti-Cancer Significant Improvement in PFS, Double ORR with Plinabulin HR = 0.76 Log rank P = 0.0082 19
Slide 20: 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% 80% P<0.0001 80% P<0.0001 Percentage of Patients Percentage of Patients 70% 70% 60% 60% 50% 50% 40% 40% 33.58% 30% 27
Slide 21: Quality of Life Benefit
Anti-Cancer Quality of Life Benefit - Q-TWiST (Quality-Adjusted Time Without Symptoms of Disease and Toxicity) Plinabulin + Docetaxel Docetaxel alone Product-Limit Survival Estimates Product-Limit Survival Estimates 1.0 + Censored 1.0 + Censored 0.8 0.8 Survival Probability Survival Probability 0.6
Slide 22: Clinical Meaningful Q-TWiST Improvement
Anti-Cancer Clinical Meaningful Q-TWiST Improvement Quality of Life was assessed with validated tools (EORTC QLQ C30 and QLQ-LC13), and the Q-TWiST analysis integrating Efficacy, Safety and Quality of Life inputs (including EQ-5D HU QoL) Improvement >18% in Q-TWiST, which is clinically meaningful. 2
Slide 23: Dublin-3: Superior Efficacy and Significant Reduction in Grade 4 CIN
Anti-Cancer Dublin-3: Superior Efficacy (OS, PFS, ORR) 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-
Slide 24: NSCLC: Favorable Benefit/Risk Profile vs. Standard of Care
Anti-Cancer NSCLC: Favorable Benefit/Risk Profile vs. Standard of Care (SOC) (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 - Consistent Long survival trend in PD-1/PD-L1 exposed patients and in we
Slide 25: Chemotherapy Induced Neutropenia (CIN)
Chemotherapy Induced Neutropenia (CIN) 25
Slide 26: Severe Unmet Medical Need is Basis for Breakthrough Designation and Priority Review
CIN Severe Unmet Medical Need is Basis for Breakthrough Designation and Priority Review for Plinabulin + G-CSF Regimen in CIN Prevention Despite widespread G-CSF use, CIN #1 reason for FN, ER visits, hospitalization, sepsis, mortality, and chemotherapy disruption1 Short-term Outcome Benefit Long-ter
Slide 27: 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 Neulasta 6 mg (n=22) • Breakthrough Therapy Designation: Unmet Plinabulin 20 mg/m2 + Neulasta
Slide 28: Protective-2 (Study 106) 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 28
Slide 29: 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% 31.5% 30% p-value=0.0015 25% Patients 20% (%) 15% 13.6% 10% 5% N=110 N=111 0% Pegfilgrastim 6 mg Plinabulin 40 mg + Pegfilgrastim 6 mg • Grade 4 neutropenia (ANC < 0.5 x
Slide 30: Favorable Benefit/Risk Ratio (Plinabulin + G-CSF vs. G-CSF alone)
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 31: NDA accepted with Priority review by U.S. and China FDA
NDA accepted with Priority review by U.S. and China FDA CIN U.S. PDUFA 11/30/2021 Seeking NDA Approval for “Plinabulin + G-CSF Combination” in a broad CIN Prevention label: all solid tumors, all chemotherapy Registration Study Supporting Studies Supporting Studies Plinabulin + G-CSF combo Plinabulin
Slide 32: Plinabulin + G-CSF Combination - Commercial Plan in CIN Prevention
Plinabulin + G-CSF Combination - Commercial Plan in CIN Prevention 32
Slide 33: 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 • Differentiated clinical cycles on time profile, potential to improve SOC DISCONTINUED chemotherapy STAY THE COURSE complete
Slide 34: 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 Cancer, Other 5% 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 35: Efficient Commercialization Plan – Concentrated Accounts, Small Salesforce
CIN Efficient Commercialization Plan – Concentrated Accounts, Small Salesforce FOCUS: Elevating the SOC in Chemotherapy 99% 100% 96% 98% 100,000 100% 94% 91% 90,000 87% 90% 85,879 81% 80,000 80% 72% Field Staff of approx. 83, including 60 sales reps Cumulative Contribution (%) 70,000 70% Patient Cou
Slide 36: Breakthrough Therapy Designation with Priority Review
CIN Breakthrough Therapy Designation with Priority Review: 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 needs: Market growth CIN: #1 reason for thera
Slide 37: Delivering the Plinabulin Value Proposition
Delivering the Plinabulin Value Proposition Near Term Opportunity Longer-Term Potential ANTI-CANCER w/ Chemotherapy Improve Survival and ANTI-CANCER Quality of Life w/ Immuno-Oncology Potential CIN APC Cornerstone of Near-Term emerging regimens Market Opportunity Raise the Standard of Care 37
Slide 38: 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 r
Slide 39: 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 40: Study Design of Plinabulin + Nivolumab + Ipilimumab in SCLC
I/O Study Design of Plinabulin + Nivolumab + Ipilimumab in SCLC Dose-escalation phase I study 3+3 Design In patients with extensive-stage SCLC who had progressed on or after prior platinum-based chemotherapy (±PD-1/PD-L1) Primary objective To determine dose-limiting toxicities (DLT’s) and recomm
Slide 41: Efficacy Analysis of Plinabulin + Nivolumab + Ipilimumab in SCLC
I/O Efficacy Analysis of 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, taking
Slide 42: Efficacy Summary
I/O Trial Results of Plinabulin + Nivolumab + Ipilimumab in SCLC (Big Ten ITT Phase 1 Study) Improvement of Overall Response Rate 46% 50% 43% 45% 40% Efficacy Summary 35% 30% 23% 25% 20% 11% 15% 10% 5% 0% Nivolumab Nivolmumab + Plinabulin + Plinabulin + Ipilimumab Nivolumab + Nivolumab + Ipilimumab
Slide 43: 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 • Durab
Slide 44: Corporate Highlights
BeyondSpring Corporate Highlights
Slide 45: Plinabulin: Near Term Milestones for Value Creation
Plinabulin: Near Term Milestones for Value Creation Anti-cancer NSCLC (with chemo): Plinabulin • Large and growing population Life-cycle Multiple Cancers (with IO): Management 2022+ • Establish as potential “cornerstone” in I/O I/O Combo combination regimens Clinical Data 2022 NSCLC CIN (broad r
Slide 46: Plinabulin: Hengrui is the Ideal Partner in Greater China
Plinabulin: Hengrui is the Ideal Partner 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: 60027
Slide 47: Hengrui Partnership Supports Key Commercialization Goals in Greater China
Plinabulin: Hengrui Partnership Supports Key Commercialization Goals in Greater China and Provides Financial Strength Manages commercialization risk and optimizes return on plinabulin franchise • Leverages existing infrastructure of leading oncology player – Minimizes launch investment and risk – Op
Slide 48: Hengrui and Wanchunbulin Partnership - Key Terms
Plinabulin: Hengrui and Wanchunbulin Partnership - Key Terms (BeyondSpring Inc. owns 58% of Wanchunbulin) Key Synergies Allow for a Mutually Beneficial “Win-Win” Deal Hengrui: Plinabulin Rights in Greater China Terms (est. USD*) • Exclusive commercialization of all • Wanchunbulin receives $30M upfro
Slide 49: 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 50: 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 51: www.beyondspringpharma.com
www.beyondspringpharma.com 51