Phase 3 asset and first-in-class molecule targeting Alzheimer’s Disease
CEO Interview
Developing the First Ever Potentially Effective Drug for Alzheimer’s
Company Overview
BioVie 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.
Interview
Positive Aging Data from Alzheimer’s Trial
Microad
BioVie's Novel Approach in the Battle Against Alzheimer's and Parkinson's
Overview
Initiating FDA Discussions to Conduct Pivotal Refractory Ascites Registrational Trial
Significant Catalysts
Poised for significant catalysts in 2023
Read out from Alzheimer’s Phase 3 anticipated by mid-2023.
Interim data read outs from planned Parkinson’s Phase 3 expected in 2023.
Multiple other efforts underway that may create additional catalysts and will be announced publicly when the company deems appropriate.
Value Proposition: Upcoming Catalysts
BioVie is poised for significant catalysts in 2023, including data read out from its Alzheimer’s Phase 3 trial, expected in Q3 2023, as well as interim data read outs from the Company’s planned Phase 3 study in Parkinson’s. BioVie has multiple other efforts underway that may create additional catalysts and will be announced publicly when the Company deems appropriate.
Investment Highlights
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 underway; ramping up 45 centers for trial; data readout anticipated by mid-2023.
$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
Positive Phase 2 data reported in Q4 2022 demonstrating improved motor control
Patients treated with NE3107 and levodopa saw a 3+ point advantage in motor control compared to those treated with levodopa alone; NE3107 patients younger than 70 years older saw twice that level of advanatage
88.9% of patients <70 years old treated with NE3107 and levodopa experienced greater than 30% part 3 score improvements from baseline
$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.
Completed Phase 3 enrollment and is expected to have topline results by Q3 2023
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 SAEs in trials thus far.
Initiating discussions with FDA for pivotal registration trial following encouraging data from Phase 2b study
Read out from Alzheimer’s Phase 3 anticipated by mid-2023.
Interim data read outs from planned Parkinson’s Phase 3 expected in 2023.
Multiple other efforts underway that may create additional catalysts and will be announced publicly when the company deems appropriate.
Microad
BioVie's Novel Approach in the Battle Against Alzheimer's and Parkinson's
Value Proposition: Upcoming Catalysts
BioVie is poised for significant catalysts in 2023, including data read out from its Alzheimer’s Phase 3 trial, expected in Q3 2023, as well as interim data read outs from the Company’s planned Phase 3 study in Parkinson’s. BioVie has multiple other efforts underway that may create additional catalysts and will be announced publicly when the Company deems appropriate.
Overview
Initiating FDA Discussions to Conduct Pivotal Refractory Ascites Registrational Trial
Investment Highlights
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 underway; ramping up 45 centers for trial; data readout anticipated by mid-2023.
$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
Positive Phase 2 data reported in Q4 2022 demonstrating improved motor control
Patients treated with NE3107 and levodopa saw a 3+ point advantage in motor control compared to those treated with levodopa alone; NE3107 patients younger than 70 years older saw twice that level of advanatage
88.9% of patients <70 years old treated with NE3107 and levodopa experienced greater than 30% part 3 score improvements from baseline
$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.
Completed Phase 3 enrollment and is expected to have topline results by Q3 2023
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 SAEs in trials thus far.
Initiating discussions with FDA for pivotal registration trial following encouraging data from Phase 2b study
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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.
