Phase 3 asset and first-in-class molecule targeting Alzheimer’s Disease
Company Overview
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
BioVie: Top-Line Results from Phase 2 Refractory Ascites Trial Expected in Early 2022
BioVie: Enrolling for Pivotal Phase 3 Trial in Alzheimer’s
BioVie: Multiple Shots on Goal with Late-Stage Assets Targeting Unmet Medical Needs
Significant Catalysts
BioVie poised for significant catalysts in 2022
Data read outs from Ascites Phase 2 and Parkinson’s Phase 2 anticipated during the first half of 2022.
Read out from Alzheimer’s Phase 3 anticipated by the end of 2022.
Multiple other efforts underway that may create additional catalysts as early as 4Q21 and will be announced publicly when the company deems appropriate.
Pipeline
Neurodegeneration
NE3107 is the only inhibitor of neuroinflammation and insulin resistance in Phase 3 clinical trials for Alzheimer’s Disease (AD)
NE3107 reduced inflammation and insulin resistance in a randomized, double-blinded, placebo-controlled Phase 2 study. Potential to address the two factors described as key drivers of cognitive decline in AD.
Phase 3 patient enrollment under way; ramping up 45 centers for trial; data readout anticipated by end of 2022.
$10+ billion annual peak sales potential.
NE3107 also being developed for Parkinson’s disease (PD) since neuroinflammation, insulin resistance, and oxidative stress are common features in AD and PD. Remarkable parallels exist between AD and PD with respect to underlying disease pathology
NE3107 was equally pro-motoric as levodopa in MPTP marmosets, decreased the severity of levodopa induced dyskinesia (LID), and preserved twice as many neurons when compared to untreated in preclinical studies.
Phase 2 trial expected to start 4Q21; data readout anticipated 2Q22.
$3+ billion annual peak sales potential.
Among competitive molecules exploring neuroinflammation and AD, NE3107 is the only one that:
Has published randomized, double-blinded, placebo Phase 2 results potentially suggesting reduction in inflammation and insulin resistance in a major population, and warranting further review in Phase 3.
Potentially inhibits both overarching mechanisms of AD pathology – inflammation and insulin resistance.
Potentially inhibits proinflammatory pathways without impacting homeostasis.
Is in Phase 3 clinical development, which is expected to have topline results by the end of 2022.
Liver Disease
BIV201 is the only drug currently in development for refractory ascites, a condition with 50% mortality rate. It has the potential to become first therapy since there are no approved drugs in the US
BIV201 is a novel formulation of terlipressin for continuous infusion; Orphan and Fast Track designations received.
Data from Europe/Asia supports development of BIV201; no drug-related AEs in trials thus far.
Phase 2b underway with data readout anticipated early 2022. Phase 3 for HRS-AKI planned for 2022.
$1.3+ billion global peak sales potential.
Experienced Leadership Team
Terren Peizer, Chairman; founded and successfully commercialized several healthcare companies. Chairman of Acuitas Group Holdings, a personal holding company that owns all his portfolio company interests, $1.5B invested directly into portfolio companies; majority shareholder of BioVie.
Cuong Do, President & CEO; former Chief Strategy Officer at Merck; a veteran biotech and pharmaceutical entrepreneur, having previously founded Callidus Biopharma (sold to Amicus Therapeutics) and M6P Therapeutics.
Jonathan Adams, EVP Liver Disease Programs; 30+ years of biopharma experience, including technology commercialization, finance, global product launches, drug marketing and sales force management.
Clarence Ahlem, EVP Neuroscience Product Development– Neurodegenerative Disease; 35+ years of experience in developing NE3107 and related assets with accomplished track record in the biopharma industry.
Chris Reading PhD, EVP Neuroscience R&D – Neurodegenerative Disease; 40+ years in biopharma; former CSO of Hollis-Eden Pharmaceuticals; MD Anderson Cancer Center; 130+ peer-reviewed publications.
J. Wendy Kim, CFO; 35 years in finance/accounting with 22 years combined experience at KPMG and BDO; as CFO managed corporate finance and operations and closed M&A transactions and secured financings.
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Stock Information
Recent Price:
Market Data
Symbol
NASDAQ: BIVI
Fiscal Year
June
Industry
Biotech
Market Cap
Shares Outstanding
Float
5.1M
Insiders Own
79.4%
Avg. Vol. (90-day)
70,203
As of
Financial Data
Cash (mrq)1
$4.5M
As of Oct 7, 2021 1does not include proceeds from $20.7M offerings in Q1 FY22
Data read outs from Ascites Phase 2 and Parkinson’s Phase 2 anticipated during the first half of 2022.
Read out from Alzheimer’s Phase 3 anticipated by the end of 2022.
Multiple other efforts underway that may create additional catalysts as early as 4Q21 and will be announced publicly when the company deems appropriate.
Pipeline
Neurodegeneration
NE3107 is the only inhibitor of neuroinflammation and insulin resistance in Phase 3 clinical trials for Alzheimer’s Disease (AD)
NE3107 reduced inflammation and insulin resistance in a randomized, double-blinded, placebo-controlled Phase 2 study. Potential to address the two factors described as key drivers of cognitive decline in AD.
Phase 3 patient enrollment under way; ramping up 45 centers for trial; data readout anticipated by end of 2022.
$10+ billion annual peak sales potential.
NE3107 also being developed for Parkinson’s disease (PD) since neuroinflammation, insulin resistance, and oxidative stress are common features in AD and PD. Remarkable parallels exist between AD and PD with respect to underlying disease pathology
NE3107 was equally pro-motoric as levodopa in MPTP marmosets, decreased the severity of levodopa induced dyskinesia (LID), and preserved twice as many neurons when compared to untreated in preclinical studies.
Phase 2 trial expected to start 4Q21; data readout anticipated 2Q22.
$3+ billion annual peak sales potential.
Among competitive molecules exploring neuroinflammation and AD, NE3107 is the only one that:
Has published randomized, double-blinded, placebo Phase 2 results potentially suggesting reduction in inflammation and insulin resistance in a major population, and warranting further review in Phase 3.
Potentially inhibits both overarching mechanisms of AD pathology – inflammation and insulin resistance.
Potentially inhibits proinflammatory pathways without impacting homeostasis.
Is in Phase 3 clinical development, which is expected to have topline results by the end of 2022.
Liver Disease
BIV201 is the only drug currently in development for refractory ascites, a condition with 50% mortality rate. It has the potential to become first therapy since there are no approved drugs in the US
BIV201 is a novel formulation of terlipressin for continuous infusion; Orphan and Fast Track designations received.
Data from Europe/Asia supports development of BIV201; no drug-related AEs in trials thus far.
Phase 2b underway with data readout anticipated early 2022. Phase 3 for HRS-AKI planned for 2022.
$1.3+ billion global peak sales potential.
Experienced Leadership Team
Terren Peizer, Chairman; founded and successfully commercialized several healthcare companies. Chairman of Acuitas Group Holdings, a personal holding company that owns all his portfolio company interests, $1.5B invested directly into portfolio companies; majority shareholder of BioVie.
Cuong Do, President & CEO; former Chief Strategy Officer at Merck; a veteran biotech and pharmaceutical entrepreneur, having previously founded Callidus Biopharma (sold to Amicus Therapeutics) and M6P Therapeutics.
Jonathan Adams, EVP Liver Disease Programs; 30+ years of biopharma experience, including technology commercialization, finance, global product launches, drug marketing and sales force management.
Clarence Ahlem, EVP Neuroscience Product Development– Neurodegenerative Disease; 35+ years of experience in developing NE3107 and related assets with accomplished track record in the biopharma industry.
Chris Reading PhD, EVP Neuroscience R&D – Neurodegenerative Disease; 40+ years in biopharma; former CSO of Hollis-Eden Pharmaceuticals; MD Anderson Cancer Center; 130+ peer-reviewed publications.
J. Wendy Kim, CFO; 35 years in finance/accounting with 22 years combined experience at KPMG and BDO; as CFO managed corporate finance and operations and closed M&A transactions and secured financings.
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BioVie (BIVI) is a client of RedChip Companies, Inc. BIVI agreed to pay RedChip Companies, Inc., a $7,500 monthly cash fee, beginning in March 2019, for 12 months of RedChip investor awareness services. The CEO of RedChip Companies owns 3,150 shares of BIVI.
Investor awareness services and programs are designed to help small-cap companies communicate their investment characteristics. RedChip investor awareness services include the preparation of a research profile(s), multimedia marketing, and other awareness services.
