Clover Biopharmaceuticals Ltd. · HKEX:2197

Clover Biopharmaceuticals — Technical Presentation (September 2021)

25 slides from Clover Biopharmaceuticals's technical presentation, Sep 22, 2021

  1. Slide 1: SCB-2019 (CpG 1018/Alum) COVID-19 Vaccine Candidate: Phase 2/3 Clinical Trial Results

    SCB-2019 (CpG 1018/Alum) COVID-19 Vaccine Candidate: Phase 2/3 Clinical Trial Results September 22, 2021 1

  2. Slide 2: Clover's COVID-19 Vaccine Candidate: SCB-2019 (CpG 1018/Alum)

    Clover’s COVID-19 Vaccine Candidate: SCB-2019 (CpG 1018/Alum)  Adjuvanted Protein-Based COVID-19 Vaccine Candidate: SCB-2019 antigen (30 µg/dose) in combination with CpG 1018 adjuvant and aluminum hydroxide (alum)  Two-dose vaccine candidate (administered 21 days apart)  Intramuscular (IM) inject

  3. Slide 3: Key Takeaways from Global Phase 2/3 Trial

    Key Takeaways from Global Phase 2/3 Trial  SPECTRA successfully enrolled over 30,000 adult & elderly participants in 5 countries across 4 continents  100% of SARS-CoV-2 strains observed in the efficacy analysis were variants (Delta was predominant strain)  Primary and secondary efficacy endpoints

  4. Slide 4: Phase 2/3 Trial Overview

    Phase 2/3 Trial Overview 4

  5. Slide 5: Phase 2/3 Efficacy Trial Initiated on 24 March 2021

    Phase 2/3 Efficacy Trial Initiated on 24 MARCH 2021 Over 30,000 participants aged 18 years or older enrolled in SPECTRA in 5 Countries across 4 Continents (South America, Asia, Europe and Africa) Philippines Colombia Brazil S. Africa Belgium 5 As of 19 MAR 2021 5

  6. Slide 6: Global Phase 2/3 Pivotal Trial Design

    Global Phase 2/3 Pivotal Trial Design Double-Blind, Randomized, Controlled Trial Evaluating Efficacy, Immunogenicity & Safety SCB-2019 (CpG 1018/Alum) 2 Injections, 21 Days Apart 30,128 N= 15,064 Adults & Elderly R Participants (1) 1:1 (≥18 Years of Age) Placebo (Saline) 2 Injections, 21 Days Apart

  7. Slide 7: Enrollment and Geographic Diversity

    Enrollment and Geographic Diversity  30,128 Adult & Elderly Participants (≥18 years of age) randomized and dosed at 31 Sites in 5 Countries across 4 Continents  Enrollment of Adolescent Participants (12-18 Years) currently ongoing Europe ~2% Belgium 709 Enrolled (3 Sites) Asia ~45% South America ~

  8. Slide 8: Demographics of Trial Participants

    Demographics of Trial Participants  Diverse & balanced populations enrolled in SPECTRA SCB-2019 (CpG 1018/Alum) Placebo Participants(1) (N) 15,064 15,064 Sex (%) Male 47.0% 46.7% Female 53.0% 53.3% Age (Years) Average Age 32.1 Years 32.0 Years (Min, Max) (18 – 86) (18 – 81) Age 18-64 98.7% 98.6% Ag

  9. Slide 9: Previous Phase Studies Were Conducted Prior to Emergence of Variants & Delta Takeover

    Previous Phase 3 Studies Were Conducted Prior to Emergence of Variants & Global Takeover by Delta  Delta (VOC) is now the dominant strain globally, responsible for >90% of COVID-19 cases worldwide  4 FDA or EMA conditionally-approved COVID-19 vaccines(1) reported efficacy in Phase 3 primarily agai

  10. Slide 10: Enables Clover to Evaluate Efficacy Against Delta in a Randomized Clinical Trial

    Enables Clover to Evaluate Efficacy Against Delta in a Randomized Clinical Trial  Delta was the predominantly circulating strain globally during SPECTRA enrollment  SPECTRA evaluated SCB-2019 (CpG 1018/Alum) against concerning variants including Delta Global SARS-CoV-2 Strain Distribution (GISAID

  11. Slide 11: Delta was the Dominant SARS-CoV-2 Strain in SPECTRA

    Delta was the Dominant SARS-CoV-2 Strain in  100% of identified SARS-CoV-2 strains observed in the efficacy analysis were variants  Globally dominant Delta was the strain most observed in SPECTRA (38% of all sequenced cases)  >85% of strains in SPECTRA were VOCs/VOIs with suspected escape mutatio

  12. Slide 12: Enrollment of Previously-Infected Individuals in SPECTRA

    Enrollment of Previously-Infected Individuals in  SPECTRA enrollment enables evaluation of efficacy & safety in previously-infected individuals in a randomized clinical trial  Previous COVID-19 vaccine clinical trials evaluated efficacy & safety primarily in SARS-CoV-2 naïve individuals (‘baseline

  13. Slide 13: Phase 2/3 Trial Results

    Phase 2/3 Trial Results 13

  14. Slide 14: 100% Efficacy Against Severe COVID-19 & Hospitalizations

    100% Efficacy Against Severe COVID-19 & Hospitalizations  100% efficacy against severe COVID-19 (any strain) (1)  100% efficacy against hospitalizations due to COVID-19 (any strain) Severe COVID-19 Hospitalizations Efficacy Any Strain Efficacy Any Strain Against: Against: 50% (4 out of 8) of sever

  15. Slide 15: Significant Overall Efficacy Against COVID-19 (Including Delta Strain)

    Significant Overall Efficacy Against COVID-19 (Including Globally-Dominant Delta Strain)  Primary efficacy endpoint successfully met; 100% of strains identified were variants (including >85% were Delta/Mu/Gamma/Beta/Theta/Lambda)  Delta: 81.7% efficacy against moderate-to-severe Delta COVID-19; 78

  16. Slide 16: Cumulative Incidence of COVID-19: Persistent Efficacy

    Significant Overall Efficacy Against COVID-19 (Including Globally-Dominant Delta Strain)  Vaccine efficacy appears to be persistent through 112 days after second dose in environment dominated by Delta and other concerning variants 8% Placebo 7% Cumulative Incidence of COVID-19 (%) 6% 5% 4% 3% 2% SC

  17. Slide 17: Significant Efficacy Also Observed Against Gamma and Mu

    Significant Efficacy Also Observed Against Gamma (VOC) and Mu (VOI)  First COVID-19 vaccine to demonstrate significant efficacy against Delta, Gamma & Mu variants (Top 3 strains in SPECTRA, comprising 73% of all strains identified)  Differences in vaccine efficacy likely driven by unique mutation

  18. Slide 18: Efficacy in High-Risk Populations (Elderly & Co-Morbidities)

    Efficacy in High-Risk Populations (Elderly & Co-Morbidities)  Trend in efficacy observed in Elderly Population; results do not suggest an age-dependent decline in efficacy  Significant vaccine efficacy observed in Participants with Co-Morbidities for COVID-19 (1) Efficacy by Age Group: Efficacy by

  19. Slide 19: SCB-2019 Significantly Reduces Risk of COVID-19 in Previously-Infected Individuals

    SCB-2019 Significantly Reduces Risk of COVID-19 in Previously-Infected Individuals  Risk of symptomatic COVID-19 reinfection reduced by 79.1% against Delta (and 64.2% any strain)  First COVID-19 vaccine globally to demonstrate efficacy & safety in previously-infected individuals  As SARS-CoV-2 co

  20. Slide 20: Favorable Safety Profile Observed

    Favorable Safety Profile Observed  SAEs, Severe AEs, MAAEs and AESIs were infrequent, and no significant differences observed compared to Placebo group  Solicited Local AEs: Mostly mild and transient  Solicited Systemic AEs: No significant differences observed compared to Placebo group  Any Soli

  21. Slide 21: Comparison of Safety Profiles (Non-Head-to-Head Data)

    Comparison of Safety Profiles (Non-Head-to-Head Data)  Favorable & Potentially-Differentiated Safety Profile Compared to Other COVID-19 Vaccines Any LOCAL AEs (After 2nd Dose) Any SYSTEMIC AEs (After 2nd Dose) SYSTEMIC AEs (After 2nd Dose) % of Participants % of Participants 0% 10% 20% 30% 40% 50%

  22. Slide 22: Comparison of Binding Antibody Titers (Head-to-Head in Same Assay)

    Comparison of Binding Antibody Titers (Head-to-Head in Same Assay)(1)  Antibody Titers In-Line or Higher Compared with 4 Approved COVID-19 Vaccines In-Line or Higher Antibody Titers Induced by Spike Binding Antibody Titers (MSD) ’s SCB-2019 (CpG 1018/Alum) Moderna mRNA-1273 Pfizer BNT-162b2 AstraZe

  23. Slide 23: Neutralizing Antibodies (Wildtype SARS-CoV-2 Neutralization Assay)

    Neutralizing Antibodies (Wildtype SARS-CoV-2 Neutralization Assay)  Strong Neutralizing Immune Responses Induced by SCB-2019 (CpG 1018/Alum)  High neutralizing antibodies induced in  Rapid & strong boosting effect induced in SARS-CoV-2 naïve participants after 2 doses previously-infected particip

  24. Slide 24: Key Takeaways from Global Phase 2/3 Trial

    Key Takeaways from Global Phase 2/3 Trial  SPECTRA successfully enrolled over 30,000 adult & elderly participants in 5 countries across 4 continents  100% of SARS-CoV-2 strains observed in the efficacy analysis were variants (Delta was predominant strain)  Primary and secondary efficacy endpoints

  25. Slide 25: Thank You

    Thank You Clover Biopharmaceuticals www.cloverbiopharma.com 25

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