Biovie Inc. · NASDAQ:BIVI
Biovie — Corporate Update (November 2023)
13 slides from Biovie's corporate update, Nov 29, 2023
Slide 1: NM101 Alzheimer's Disease Phase 3 Topline Readout
NM101 Alzheimer’s Disease Phase 3 Topline Readout November 2023
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains statements about BioVie’s future expectations, plans, strategies and prospects which constitute forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Refo
Slide 3: Overview
Overview • NE3107 appears to be biologically active • Cognitive, functional, biomarker efficacy signal suggest that NE3107: – Has a treatment advantage equal to or greater than results reported from clinical trials from approved monoclonal antibody treatments; – Associated with a benign safety profi
Slide 4: Trial Timeline and Enrollment
Trial Timeline and Enrollment • The company monitors blinded data to track safety and ensure timely data entry into the EDC • The Company started noticing unusual data patterns when enough patients completed the trial. Pentara (a leading AD biostatistics firm) reviewed the blinded data and found: –
Slide 5: Safety Profile
Safety Profile NE3107 Placebo Total NE3107 Placebo Total NE3107 Placebo Total COVID-19 9.5% 17.6% 13.2% Atrioventricular block first degree 2.4% 0.0% 1.3% Hypothyroidism 2.4% 0.0% 1.3% Urinary tract infection 7.1% 8.8% 7.9% Bile duct stone 0.0% 2.9% 1.3% Hypoxia 0.0% 2.9% 1.3% Blood thyroid stimulat
Slide 6: Data From All Sites In One Geographic Area Had Data Unlike All Other Sites
Data From All Sites In One Geographic Area Had Data Unlike All Other Sites All Sites In Affected Geographic Area All Sites Oustide Affected Geographic Area 0.0 2.0 LS Mean with Standard Error Change from Baseline LS Mean with Standard Error Change from Baseline Improvement Improvement -0.2 1.5 CDR-S
Slide 7: Baseline Characteristics of Per-Protocol Population
Baseline Characteristics of Per-Protocol Population NE3107 Placebo N 24 33 Age – Mean years (Standard Deviation) 75.1 (6.4) 74.9 (5.9) <70 years 25.0% 24.2% >=70 75.0% 75.8@ Gender Male 37.5% 51.5% Female 62.5% 48.5% Race Asian 0% 9.1% Black/African American 8.3% 3.0% Caucasian 91.7% 84.8% Mot Repor
Slide 8: Week 30 Suggest NE3107 Advantage vs. Placebo is Comparable to or Better than Results
Week 30 Suggest NE3107 Advantage vs. Placebo is Comparable to or Better than Results Reported from Clinical Trials by Approved Medications Change from baseline Placebo Decline NE3107 NE3107 vs. Placebo Comparator (18 mos) CDR-SB +1.39 +0.44 -0.95 (68%) -0.45 (27%)1 (lower is improvement) (p=0.0125;
Slide 9: NE3107-treated Patients' Changes in CDR-SB Appears Correlated with Key Biomarkers
NE3107-treated Patients’ Changes in CDR-SB Appears Correlated with Key Biomarkers TNFα Phospho-Tau Aβ42 / Aβ40 Improvement Improvement Slope = -0.239 R = -0.239; p = 0.260 Aβ42 / Aβ40 CFB TNFα CFB pTau CFB Improvement Slope = 0.077 R = 0.466; p = 0.244 Slope = 0.047 R = 0.325; p = 0.140 CDR-SB CFB C
Slide 10: NE3107 Appears to Decrease the Neuroinflammatory Processes that Link Nf-L and GFAP to Cognitive Decline
NE3107 Appears to Decrease the Neuroinflammatory Processes that Link Nf-L and GFAP to Cognitive Decline Placebo NE3107 Slope = 3.44 Slope = -0.035 R = 0.610; p = 0.002 R = -0.009; p = 0.968 Nf-L CFB Nf-L CFB Nf-L CDR-SB CFB CDR-SB CFB Placebo NE3107 Slope = 1.61 R = 0.069; p = 0.761 GFAP CFB GFAP Sl
Slide 11: NE3107-treated Patients Experienced Significant Age Deceleration
NE3107-treated Patients Experienced Significant “Age Deceleration” in a Manner Correlated to Cognitive and Functional Improvements Age Deceleration1 is used by longevity researchers2 to measure the difference between a person’s 10 biological age and the actual chronological age. 5 Placebo NE3107 Age
Slide 12: Recap
Recap • NE3107 appears to be biologically active • Cognitive, functional, biomarker efficacy signal suggest that NE3107: – Has a treatment advantage equal to or greater than results reported from clinical trials from approved monoclonal antibody treatments; – Associated with a benign safety profile
Slide 13: Thank You
Thank You