Biovie Inc. · NASDAQ:BIVI

Biovie — 2024 World Congress on Parkinson's Disease and Related Disorders

13 slides from Biovie's conference presentation, May 2024

  1. Slide 1: Improvement of Motor and Non-Motor Symptoms with Bezisterim Adjunctive to Carbidopa/Levodopa in PD

    IMPROVEMENT OF MOTOR AND NON- MOTOR SYMPTOMS WITH BEZISTERIM ADJUNCTIVE TO CARBIDOPA/LEVODOPA IN PATIENTS WITH PARKINSON’S DISEASE: A PHASE 2A, PLACEBO-CONTROLLED STUDY Joseph Palumbo1; Christopher L. Reading1; Clarence Ahlem1; Nily Osman2; Jeffrey Zhang1,3; Jason L. Aldred4; Ramon L. Rodriguez5; Ed

  2. Slide 2: Background

    Background Bezisterim (NE3107) is hypothesized to disrupt PD pathogenesis via its anti- inflammatory and insulin-sensitizing actions NE3107 MAPK IL-1β Chronic TNF-α TNFR1 NF-κB ERK TNF-α inflammation Stimuli Activated Pro-inflammatory cytokines Insulin Up to (eg, α-synuclein) microglia resistance ~6

  3. Slide 3: Study Design: Phase 2, Double-Blind, Placebo-Controlled, 28-Day Duration

    Study Design: Phase 2, Double-Blind, Placebo-Controlled, 28-Day Duration Inclusion criteria • 30-80 years old NE3107 20 mg + IR C/L • Diagnosis of PD BID 12 hours apart • Bradykinesia and motor response to 1:1 Active Treatment, 27 days levodopa Safety follow-up • History of motor fluctuations + Day

  4. Slide 4: Bezisterim Associated With Superior Improvements Versus Placebo on MDS-UPDRS Part III

    Bezisterim Treatment Was Associated With Superior Improvements Versus Placebo on the Motor Examination Part (Part III) of the MDS-UPDRS, With Greatest Improvement in Patients <70 Years old All Patients Patients <70 years old Time Point Time Point (hours post dose) 0 1 2 3 4 8 (hours post dose) 0 1 2

  5. Slide 5: More Bezisterim-Treated Patients Experienced Morning ON State on Day 28

    More Bezisterim-levodopa Combination Treated Patients who Experienced an “OFF” State at Baseline Experienced a Morning “ON” State Prior to Dosing on day 28 Post hoc efficacy assessment NE3107 Placebo 0 (0%) 6 (30%) "OFF" state "OFF" state "ON" state "ON" state 14 (70%) 19 (100%) P=0.02 • 30% (6/20)

  6. Slide 6: Significant Improvement in the NMSS Sleep/Fatigue Domain Score

    Significant Improvement in the NMSS Sleep/Fatigue Domain Score Improvements were correlated with Motor Score improvements P=0.0159b 2 Cohen’s d = -0.5 Change From Baseline in NMSS Total Scorea 1.0 1 Bezisterim (n=20c) 0 Placebo (n=17c) Improvement −1 −2 −2.4 −3 Sleep/fatigue domain improvements sign

  7. Slide 7: Significant Improvement in Fatigue/Lack of Energy (Q4) With Bezisterim

    Significant Improvement From Baseline in Fatigue/Lack of Energy (Q4) Achieved With Bezisterim but Not Placebo Does fatigue (tiredness) or lack of energy (not slowness) limit the patient’s daytime activities? All Patients Patients With Symptoms at Baseline Bezisterim Placebo Bezisterim Placebo (n=20b

  8. Slide 8: Significant Improvement in Urge to Move Legs/Restlessness in Legs (Q6)

    Significant Improvement From Baseline in Urge to Move Legs/Restlessness in Legs (Q6) Achieved With Bezisterim but Not Placebo Does the patient experience an urge to move the legs or restlessness in legs that improves with movement when he/she is sitting or lying down inactive? All Patients Patients

  9. Slide 9: Conclusions

    Conclusions • These data suggest that as an adjunctive therapy to levodopa, bezisterim may hold promise in ameliorating specific non-motor symptoms of PD, particularly in sleep/fatigue items of domain 2 of the NMSS related to fatigue/lack of energy and restlessness of the legs • These findings warra

  10. Slide 10: Disclosures

    Disclosures CLR, CA, and JP are employees of BioVie Inc. NO is formerly an employee of BioVie Inc. JZ is a consultant for BioVie Inc. SHI and AEL have served as advisors for BioVie Inc. RLR and RK have received grants from BioVie Inc. Acknowledgments p-value communications provided editorial support

  11. Slide 11: References

    References 1. Troncoso-Escudero P, Parra A, Nassif M, Vidal RL. Outside in: unraveling the role of neuroinflammation in the progression of Parkinson’s disease. Front Neurol. 2018;9:860. doi: 10.3389/fneur.2018.00860 2. Athauda D, Foltynie T. Insulin resistance and Parkinson’s disease: a new target f

  12. Slide 12: Back up slides

    Back up slides 12

  13. Slide 13: Baseline Characteristics

    Baseline Characteristics Characteristic NE3107 + IR C/L (n=24) Placebo + IR C/L (n=22) Age, mean (y) 67.4 65.8 Gender, n (%) Female 10 (41.7) 8 (36.4) Male 14 (58.3) 14 (63.6) Weight, mean (kg) 80.1 80.8 BMI, mean (kg/m2) 27.6 26.4 Time since diagnosis, mean (y) 7.6 7.2 Total daily levodopa, mean (m

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