Beyondspring, Inc. · NASDAQ:BYSI

Beyondspring — Investor Presentation (March 2025)

52 slides from Beyondspring's investor presentation, March 2025

  1. Slide 1: March 2025 | NASDAQ: BYSI

    March 2025 | NASDAQ: BYSI

  2. 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

  3. Slide 3: Investment Highlights

    Investment Highlights Plinabulin Favorable > 700 Cancer Patients Treated with Good Tolerability Safety Profile Positive Phase 3 study in 2L/3L NSCLC with Overall Survival Benefit: Anti-cancer Efficacy 1. durable anti-cancer benefit in doubling 2-year, 3-year OS rate 2. enables more chemo doses by re

  4. Slide 4: Pipeline

    Pipeline Indication/Target Program Preclinical Phase 1 Phase 2 Phase 3 Registration Trial Name / Collaborator Study 103 (DUBLIN-3) NSCLC - Presented at ISLAC, ESMO 2024 Plinabulin + Docetaxel Late stage (2nd/3rd line) Published in “LANCET Respiratory Medicine” 09/2024 Plinabulin + Studies 105 & 106

  5. Slide 5: Sale of a Portion of Equity Interest in SEED to Advance Lead Asset Plinabulin

    Sale of a Portion of Equity Interest in SEED to Advance Lead Asset Plinabulin in Anti-Cancer Clinical Development • $35.4 M gross proceeds for non-diluting financing by selling a portion of SEED A-1 shares o Strategically positioned to advance our 303 and 302 studies in Plinabulin combination with i

  6. Slide 6: Plinabulin: First-in-class Late-Stage Clinical Asset for Cancer Treatment

    Plinabulin: First-in-class Late-Stage Clinical Asset for Cancer Treatment 6

  7. Slide 7: Plinabulin: Induces Innate and Adaptive Immunity via Dendritic Cell Maturation

    Plinabulin: Induces Innate and Adaptive Immunity via Dendritic Cell (DC) Maturation By depolymerizing microtubules, plinabulin releases and activates immune-defense protein GEF-H1 Plinabulin is a unique tubulin binder and Plinabulin Novel Target GEF-H1 activates does not change tubulin dynamics RhoA

  8. Slide 8: Triple IO combo: Potential in Re-sensitizing Patients who Failed Prior Immunotherapies

    Triple IO combo: Plinabulin+PD-1/L1+Chemo/RT’s Potential in Re-sensitizing Patients who Failed Prior Immunotherapies, a High Unmet Medical Need Acquired resistance to PD-1/L1: “T cell exhaustion” or “antigen presenting cell pathway mutation”1. ② Plinabulin (DC Maturation) Improved antigen presentati

  9. Slide 9: Plinabulin's Immunomodulation and Neutropenia-Mitigating Activities

    Plinabulin’s Immunomodulation and Neutropenia-Mitigating Activities Position it as a Valuable Addition for Immuno-Chemotherapy Combination Regimens These aspects result in an optimal scenario of added efficacy with potentially reduced toxicity. Dendritic Cells Tumor Vasculature Improves safety* Plin

  10. Slide 10: Plinabulin Clinical Studies in Multiple Cancers

    Plinabulin Clinical Studies in Multiple Cancers >700 cancer patients treated with Plinabulin with good tolerability Indication/Target Program Preclinical Phase 1 Phase 2 Phase 3 Registration Trial Name / Collaborator NSCLC Study 103 (DUBLIN-3) Plinabulin + Docetaxel (2nd/3rd line) - OS, PFS, ORR ben

  11. Slide 11: Plinabulin Improves Overall Survival and Enhances Safety in 2L/3L NSCLC (Dublin-3 Study)

    Plinabulin Improves Overall Survival and Enhances Safety in 2L/3L NSCLC (Dublin-3 Study) • The Lancet Respiratory Medicine (Sept 9, 2024) • BeyondSpring Delivers Oral Presentation at ISLAC 2024 World (globenewswire.com) • BeyondSpring Presents Final Data Analysis of DUBLIN-3 (globenewswire.com) 11

  12. Slide 12: 2L/3L NSCLC Has Been a Historically Difficult Space in Which to Develop

    2L/3L NSCLC (No Driver Mutation) Has Been a Historically Difficult Space in Which to Develop Treatment options in 2L/3L NSCLC are limited • Docetaxel-based therapies remains the standard of care in 2L/3L NSCLC (EGFR wild type). No new therapy approved in the last 10 years. • However, docetaxel-based

  13. Slide 13: Plinabulin Evaluated with Docetaxel in a Phase 3 Study in Pre-treated NSCLC

    Plinabulin Has Been Successfully Evaluated with Docetaxel in a Phase 3 Study with Advanced and Metastatic, Pre-treated NSCLC EGFR Wild Type Patients Docetaxel + Plinabulin vs. Docetaxel + Placebo in Patients with EGFR Wild-Type NSCLC Study Plan Primary endpoint Secondary endpoints • Global, randomiz

  14. Slide 14: Balanced Baseline Characteristics

    Balanced Baseline Characteristics Docetaxel + Placebo (n=281) Docetaxel + Plinabulin (n=278) Median age, y (range) 60 (25, 85) 61 (37, 82) Sex, n (%) Male 207 (73.7) 199 (71.6) Female 74 (26.3) 79 (28.4) Tumor histology, n (%) Non-squamous 178 (63.3) 154 (55.4) Squamous 100 (35.6) 120 (43.2) Missing

  15. Slide 15: Plinabulin + Docetaxel Met its Primary Endpoint (OS)

    Plinabulin + Docetaxel Met its Primary Endpoint (OS) and Showed Significant Improvement in Long-term OS Rate Docetaxel + Docetaxel + placebo Plinabulin Survival Probability (%) OS HR=0.82 mOS benefit 1.1 M Log rank p=0.0399 Log-rank p=0.0399 Months Subjects at Risk Docetaxel (75mg/m2) + placebo 281

  16. Slide 16: Plinabulin + Docetaxel Significantly Improved PFS and ORR

    Plinabulin + Docetaxel Significantly Improved PFS and ORR PFS ORR ORR (CR+PR)a, n (%) 16 DP: 14% 14 12 10 D: 9% 8 6 4 2 0 Docetaxel + Placebo Docetaxel + Plinabulin ITT N Median PFS Month HR Log rank (95% CI) P value P value = 0.0404 Docetaxel (D) 281 2.8 (2.76, 2.93) Plinabulin + 278 3.3 (2.89, 3.8

  17. Slide 17: Plinabulin Increases Cycles of Treatment and Improved OS Benefit

    Plinabulin Increases Cycles of Treatment and Improved OS Benefit with More Cycles of Treatment OS K-M Graph for treatment cycles ≥4 cycles Consistently improved median OS observed Docetaxel + plinabulin Docetaxel + placebo Censored with more treatment cycles 100 80 Survival Probability (%) 60 40 20

  18. Slide 18: Plinabulin Significantly Reduce Grade 4 Neutropenia with less use of G-CSF

    Plinabulin Significantly Reduce Grade 4 Neutropenia (>80% reduction) with less use of G-CSF Use of plinabulin significantly reduced Grade 4 neutropenia Less Use of G-CSF use in each Grade 4 neutropenia, All Cycles Day 8 treatment cycle for Plinabulin Arm 50% Docetaxel + Docetaxel + P<0.0001 Treatmen

  19. Slide 19: Consistent OS Benefit in 24-month follow up; Non-squamous OS HR=0.72

    Consistent OS Benefit in 24-month follow up after Database Lock; Non-squamous OS HR=0.72 ITT Non-squamous ITT N Median OS (95% CI) HR Log rank Non-squamous N Median OS (95% CI) HR Log rank P value P value Docetaxel 281 9.3 (8.35, 10.65) Docetaxel 178 8.81 (7.73, 10.65) Plinabulin + 278 10.8 (9.37, 1

  20. Slide 20: DUBLIN-3: Treatment Related Adverse Events

    DUBLIN-3: Treatment Related Adverse Events Docetaxel + Placebo Docetaxel + Plinabulin N=278 N=274 n (%) n (%) TEAE All grades Grade 3 Grade 4 All grades Grade 3 Grade 4 Any 276 (99.3) 85 (30.6) 119 (42.8) 273 (99.6) 141 (51.5) 52 (19.0) Hematological Anemia 121 (43.5) 13 (4.7) 0 137 (50.0) 15 (5.5)

  21. Slide 21: Plinabulin Successfully Improved Overall Survival Relative to SOC in 2L/3L NSCLC

    Plinabulin Successfully Improved Overall Survival Relative to SOC in 2L/3L NSCLC, an Achievement that has Eluded Other Novel Approaches The addition of plinabulin as a single agent added to 2L/3L NSCLC (EGFR wt) standard-of-care docetaxel led to improved overall survival and enhanced safety Efficacy

  22. Slide 22: Phase 1b IIT Study: Plinabulin Triple IO Regimen in Resensitizing Patients who Failed PD-1/L1

    Phase 1b IIT Study: Plinabulin Triple IO Regimen in Resensitizing Patients who Failed PD-1/L1 in Multiple Cancers MD Anderson Cancer Center Presentation at SITC Conference (Nov 2023); Manuscript Under Review 22

  23. Slide 23: Phase 1b Study to Evaluate Safety of Adding Plinabulin + RT + PD-1

    Phase 1b Study to Evaluate Safety of Adding Plinabulin + RT + PD-1 in IO Relapsed/Refractory Solid Tumors (Plinabulin use after RT) Baseline Eligibility: Cycle 1 Cycle 2-Cycle N C1D4 C3D1 • Any cancer w/ progression • RT start D1 (3-5 fx) on prior SOC anti-PD-1/PD-L1 • Plinabulin 3-6 hr after • Plin

  24. Slide 24: Responding Patients Show Early Immune Activation via Rapid DC Maturation

    Plinabulin-Responding Patients Show Early Immune Activation Evidenced by Rapid DC Maturation in the Peripheral Blood Phase 1b study in a number of IO Relapsed/Refractory solid tumors, rapid DC maturation at cycle 1 Day 4 (in blood samples) were observed in plinabulin-responding (PR + SD) patients De

  25. Slide 25: Clinical PoC in Efficacy: Plinabulin Triple Combo Produces Clinically Meaningful Responses

    Clinical PoC in Efficacy: Plinabulin Triple Combo Produces Clinically Meaningful Responses in the Non-Irradiated Tumor Across Multiple Cancers in CINR Topline Preliminary Data: presented at SITC 2023: Systemic abscopal effect seen comparing baseline and C3D1 Plinabulin triple combination led to >50%

  26. Slide 26: Plinabulin with Radiation and Checkpoint Inhibitors Induces DC Maturation

    Plinabulin, Combined with Radiation and Immune Checkpoint Inhibitors, Induces DC Maturation and Potentially Re-sensitizes IO-failure Tumors Plinabulin is a Unique Strong Preclinical Clinical Evidence of Clinical Evidence of Tubulin Binder Proof of Concept Efficacy Immune Activation Plinabulin’s tubu

  27. Slide 27: Phase 2 IIT (303 Study): Pembrolizumab plus Plinabulin and Docetaxel in Metastatic NSCLC

    Phase 2 IIT (303 Study): Pembrolizumab (Pemb) plus Plinabulin (Plin) and Docetaxel (Doc) in Metastatic NSCLC Patients (pts) Who Progressed on First-Line Immune Checkpoint Inhibitor Peking Union Medical Hospital, Beijing, China Presentation at ESMO (Sept 2024) and SITC Conference (Nov 2024) 27

  28. Slide 28: Limited Options for 2L/3L NSCLC Patients Who Failed Prior PD-1/L1 Inhibitor

    Limited Options for 2L/3L NSCLC Patients Who Failed Prior PD-1/L1 Inhibitor Historical Comparison Data • Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations who progress on immune checkpoint inhibitors (ICI) with and without standard chemotherapy.  Se

  29. Slide 29: IIT Phase 2 303 Study: 2L/3L NSCLC, All Progressed on PD-1/L1

    IIT Phase 2 303 Study: 2L/3L NSCLC, All Progressed on PD-1/L1 N=47 Regimen Endpoints • Metastatic NSCLC • Progressed from PD-1/L1 • Pembrolizumab 200mg • Primary: monotherapy or in comb with D1 Q3W (up to 35 cycles) -ORR (RECIST 1.1) platinum doublet • Plinabulin 30mg/m2 D1 • 1L PFS > 6 months Q3W(U

  30. Slide 30: Efficacy data (cut-off 29-Aug-2024) – 2024 SITC Presentation

    Efficacy data (cut-off date on 29-Aug-2024) – 2024 SITC Presentation Updated Analysis: 30 patients (ITT) median follow-up time: 11.5 month (m) Histology Best Change (%) in Target Lesions Sum of Diameters (SOD) and PFS Squamous 43% Non-squamous 57% Primary endpoint Confirmed ORR (RECIST 1.1) 21.1% Se

  31. Slide 31: Safety Summary: Treatment-related adverse events

    Safety Summary Treatment-related adverse events (CTCAE 5.0 ≥ Grade 3) 31

  32. Slide 32: Phase 2 IIT - 303 Study Summary

    Phase 2 IIT - 303 Study Summary Efficacy • Easy to use regimen (Pemb + Plin + Doc on day 1 of each cycle) in patients with metastatic NSCLC who had disease progression after clinical benefit with PD-1/PD-L1 (with 80% as pemb) showed encouraging clinical benefit for 30 patients of m PFS (8.6 months)

  33. Slide 33: First-in-class agent Plinabulin: Transforming Oncology with Novel Mechanisms

    First-in-class agent Plinabulin: Transforming Oncology with Novel Mechanisms and Clinically Meaningful Patient Benefits Unmet Medical needs and Strong global patent Unique MOA Clinical Success Market Potential protection A unique tubulin modulator Successfully demonstrated Clinically enhanced the an

  34. Slide 34: SEED Therapeutics: Target Protein Degradation (TPD 2.0) Company

    SEED Therapeutics: Target Protein Degradation (TPD 2.0) Company TPD Targets 80% of Disease-Causing Proteins That are Currently Undruggable 34

  35. Slide 35: Investment Highlights

    Investment Highlights SEED is a leading Targeted Protein Degradation (TPD) 2.0 company focusing on developing novel “Molecular Glues” (MG) for breakthrough therapeutics TPD Focusing on Molecular Glues (MG) to address 80% of disease-causing proteins considered "undruggable" by Commercial traditional

  36. Slide 36: Targeted Protein Degradation (TPD)

    Targeted Protein Degradation (TPD) TPD for 80%Undruggable Proteins TPD Research is an Important and High-value Area - E3 ligase is the key protein which recognizes the - Large Pharma In-license and Collaboration Activities disease protein (POI) for degradation • Discovery-Stage TPD Assets: Command $

  37. Slide 37: Experienced Team with Success Track Record

    Experienced Team with Success Track Record Management Team Board Members Founders Experienced business and Nobel Prize winner, 40 IND and 12 NDA legal expert and independent Pioneers in TPD Space experience board member from Eli Lilly and Eisai 37

  38. Slide 38: World Class Founding and Leadership Team

    World Class Founding and Leadership Team Lan Huang, PhD + * Avram Hershko MD, PhD+ Ning Zheng, PhD+ Michele Pagano, MD + (Chairman & CEO) “Godfather” of TPD; Howard Hughes Professor, University of Howard Hughes Professor, NYU E3 structural expert; Serial biotech 2004 Nobel Laureate; Washington; Worl

  39. Slide 39: Technology Platform: RITE3 – Target-Centric TPD 2.0

    Technology Platform: RITE3 – Target-Centric TPD 2.0 Quasi-Interface Analyses LumID: identify the right E3 near Basal Affinity Validation POI in live cell B B E3 B Target Protein Target Quasi Degron Protein Target B 1 Weakened Binding A I L A I L E3 A E3 C E3 E3 Molecular Glue Proteomics B B E3 B B 

  40. Slide 40: Nature Biotechnology Review on The Glue Degraders

    “Nature Biotechnology” Review on “The Glue Degraders” (3/6/2024) SEED was prominently featured in “Nature Biotechnology” Review. Garber, Nature Biotechnology (2024) 40

  41. Slide 41: Nature Reviews Drug Discovery Review on Protein Degraders

    “Nature Reviews Drug Discovery” Review on “Protein Degraders Push into Novel Target Space” (10/14/2024) SEED was prominently featured in “Nature Reviews Drug Discovery”. Mullard, Nature Reviews Drug Discovery (2024) 41

  42. Slide 42: Pipeline: Diversified and Fast Progressing

    Pipeline: Diversified and Fast Progressing Target Molecular IND Indication Target Protein E3 Ligase ID Lead ID IND Filing Selection Glue HTS Candidate RBM39 FHD Expected KRAS-G12D in 2H 2025 Oncology Target Beta FEN1 Target Alpha* In Vivo Activity Neurodegeneration Tau Expected in 2H 2025 Target Del

  43. Slide 43: Pipeline: Rapid Progress and High-Value Potential

    Pipeline: Rapid Progress and High-Value Potential Program Indication Milestones Market Potential RBM39 Degrader Liver cancer, KRAS-mutant Expected: IND submission mid-2025, first human dose H2 Peak sales >$7B (ST-01156) cancers, neuroblastoma 2025; clinical data for around 50 patients H2 2026 Expect

  44. Slide 44: RBM39 Degrader: RNA Splicing for Various Cancers

    RBM39 Degrader: RNA Splicing for Various Cancers RBM39: RNA splicing protein RNA splicing selects Exons and removes Introns to form normal mRNA and proteins RBM39 degradation kills cancer cells through RNA splicing defects of key target genes Molecular Glue E3 Han et al., Science, 2017 44

  45. Slide 45: RBM39 Degradation: Recognized as a Validated Target

    RBM39 Degradation: Recognized as a Validated Target Discovery Timeline of Aryl Sulfonamides 1998 Indisulam (E7070) was discovered by Eisai as a 2004 carbonic anhydrase inhibitor and was introduced into E7820 was discovered by Eisai as a tumor angiogenesis clinical trial. inhibitor and was introduced

  46. Slide 46: ST-01156 (IND Candidate) – Total Tumor Regression in Animal Model

    ST-01156 (IND Candidate) – Total Tumor Regression in Animal Model Colon Cancer (KRAS G13D) HCT-116 Neuroblatoma SH-SY5Y 120 120 % Inhibition of CTG signal % Inhibition of CTG signal ST-00937 ST-00937 ST-01156 80 80 ST-01156 IND candidate ST-01156 40 Demonstrates total tumor 40 regression in an Orpha

  47. Slide 47: ST-01156: Oral RBM39 Degrader Advancing to Clinical Trials in 2025

    ST-01156: Oral RBM39 Degrader Advancing to Clinical Trials in 2025 SEED Focus on Successful Clinical Testing in MOA-based Indications with Speed to NDA • MOA understanding and preclinical screening on patient-derive models provide the opportunity for rationale clinical indication selection, with inc

  48. Slide 48: RBM39 Degrader: Clinical Development Plan - Precision Medicine Approach

    RBM39 Degrader: Clinical Development Plan - “Precision Medicine” Approach 2025 2026 2027 2028 2H’25 to 2H’26 Phase 1 2H’26 to 1H’28 Safety + Preliminary Efficacy Phase 1b / Phase 2 All comer solid tumors, enriched Expansion Cohort for • “MOA Targeted” Indications: • Potential to enroll pediatric pat

  49. Slide 49: Global Pharma Partnerships: Validating SEED's Leadership in TPD Space

    Global Pharma Partnerships: Validating SEED’s Leadership in TPD Space • SEED entered a research collaboration with Eli Lilly on TPD with multiple targets since SEED’s inception in November 2020. • Under the terms of the collaboration agreement with Lilly, SEED received a $10 million upfront cash pay

  50. Slide 50: Upcoming Catalysts

    Upcoming Catalysts Strengthening RITE3 Platform Advancing Internal and R&D Pipelines with Lilly and Eisai 2H 2025 Catalysts: 2H 2026 Catalysts: • SEED’s lead oncology asset RBM39 • Safety, target engagement and clinical response data degrader expected to enter IND in mid- available for SEED’s RBM39

  51. Slide 51: Investment Highlights

    Investment Highlights Plinabulin: Safety & Lead Asset Plinabulin: >700 cancer patients treated with good Efficacy tolerability; Positive Phase 3 data in 2/3L NSCLC, EGFR wild type Plinabulin: Dual Benefit in anti-cancer and prevention of CIN; Potential Plinabulin Potential in re-sensitizing in PD-1/

  52. Slide 52: www.beyondspringpharma.com

    www.beyondspringpharma.com 52

BeyondSpring — Investor Presentation (March 2025) on 6ix