Biovie Inc. · NASDAQ:BIVI
Biovie — RedChip Group Investor Webinar December 2023
12 slides from Biovie's conference presentation, Dec 7, 2023
Slide 1: RedChip Group Investor Webinar
RedChip Group Investor Webinar December 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: Week 30 Suggest NE3107 Advantage vs. Placebo
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 5: 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 6: NE3107 Appears to Decrease the Neuroinflammatory Processes that Link Nf-L and GFAP
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 7: 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 8: Questions We Have Been Asked
Questions We Have Been Asked • When did we know that the initial 6 sites need to be excluded? The additional 9 sites? • What data did we exclude from what was presented at CTAD? • Why didn’t we exclude data from all 15 sites? • Did we knowingly present suspected data to pump the stock price? • What’
Slide 9: Timeline
Timeline Sept • Pentara noticed unusual patterns with some sites and a • Blinded data particular demographic group. constantly monitored Formal report Sept 26 Nov 6 from start of trial • Without unblinding and PK • Supplemental CRO’s report Nov 21-22 • BioVie’s CRAs started data, cannot explain and
Slide 10: 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 11: 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 12: Thank You
Thank You
BioVie — RedChip Group Investor Webinar December 2023 on 6ix