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Developing Transformative
Therapies to Overcome
Chronic Debilitating Diseases
Corporate Presentation • June, 2021
©2021 BioVie Inc.
Forward-looking statements
2
This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and
experience to differ materially from anticipated results and expectations expressed in these forward-looking statements.
BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes,"
"estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other
factors that could cause actual results to differ materially from those expressed in forward-looking statements are: successful
completion of the acquisition of the biopharmaceutical assets from NeurMedix Inc., BioVie’s need for, and the availability of,
substantial capital in the future to fund its operations and research and development. Other risks are that BioVie’s
compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and
marketed in the United States or elsewhere. BioVie cannot guarantee the effectiveness of its patents or Orphan Drug
designations. A more complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange
Commission. In addition to the risks described above and in BioVie’s filings with the Securities and Exchange Commission,
other unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed
and actual results may differ materially from such statements. You should not place undue reliance on any forward-looking
statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking
statements that may be made to reflect events or circumstances after the date of that these slides are posted to BioVie’s
website or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Vision for BioVie
©2021 BioVie Inc. 3
Biopharma company focused on multiple therapeutic areas with unmet medical
needs
• Advanced liver cirrhosis
• Neurodegenerative disease
• Oncologic applications
Investment Highlights
4
NE3107: inhibitor of pathologic inflammation and insulin resistance with
low expected toxicity and immunosuppression. Alzheimer’s Phase 3
starting mid-2021. Parkinson’s, multiple myeloma, prostate cancer follow
BIV201: Orphan drug candidate in Phase 2b for refractory ascites; HRS-
AKI trials planned. Ascites readout anticipated in early 2022
Multiple shots on goal focused on unmet medical needs: advanced liver
disease, neurodegenerative, oncology
Capital efficient development plans with expected near-term data
readouts
©2021 BioVie Inc.
Leadership Team
5
Cuong Do
President & Chief
Executive Officer
• 30+ years in
biopharma &
technology
• President, Samsung
Global Strategy
Group
• Chief Strategy
Officer for Merck
• Senior partner at
McKinsey &
Company
Jonathan Adams
Liver Cirrhosis
Program
• 30+ years in
biopharma
• Founded LAT
Pharma (BioVie
predecessor)
• Mission Pharmacal
• Corbett and other
healthcare agencies
• Searle
Pharmaceuticals
J. Wendy Kim
Chief Financial
Officer
• 35 years in finance/
accounting
• As CFO managed
corporate finance
and operations
groups
• Closed M&A
transactions and
secured financings
• Combined 22 years
at KPMG and BDO
LLP
Chris Reading, PhD
Neurodegenerative
Disease Program
• 40+ years in biopharma
• Chief Scientific Officer,
Hollis-Eden
Pharmaceuticals
• VP of Product and
Process Dev. for
Systemix
• U Texas Dept. of Tumor
Biology
• MD Anderson Cancer
Center
• Over 130 peer-reviewed
publications
Clarence Ahlem
Neurodegenerative
Disease Program
• 35+ years in
biopharma
• Vice President,
Product Development
Harbor Therapeutics
• Director, Product
Development, Hollis-
Eden Pharmaceuticals
• SyStemix
• Hybritech
• US San Diego
©2021 BioVie Inc.
Disease Target: Refractory Ascites
©2021 BioVie Inc. 6
6
* TIPS = transjugular intrahepatic portosystemic shunt to channel blood flow around the liver
Our first disease
target is ascites,
the accumulation
of 5+ liters of
fluid in the
abdomen.
Refractory ascites patients typically undergo paracentesis
to remove ascites fluid every week to 10 days
Paracentesis:
• Withdrawal of 5–10L of ascites fluid (on average) from
abdomen using a large bore needle
• Provides a few days of symptomatic relief
• The kidneys are “burning out” by retaining massive
quantities of salt and water
• Patients suffer frequent life-threatening complications
• No remaining options except for TIPS* surgery or
liver transplant
• Estimated $670 million addressable US market with
20,000 targeted patients
• No drugs ever approved by FDA to treat ascites
Novel Prefilled Syringe with Patent-pending
Liquid Formulation
7
• Global PCT filed to protect our novel liquid formulation
• Accurate dosing: Eliminates mixing minute quantities of powder terlipressin that
could result in medication errors or sterility loss
• Enhanced convenience: Simply inject fluid into the saline bag and attach to pump
BIV201 Prefilled Syringe
Stable for 12+months at room temp.
Needle or
Connector
50 mL bag of saline for
insertion into pump
Portable pump
Carried in small satchel
©2021 BioVie Inc.
BIV201 Development Plans
8
Ascites
• Revised Phase 2b protocol and CMC package covering
prefilled syringe cleared by FDA
• 20 to receive BIV201 therapy + standard of care (SOC);
10 to receive SOC only (control group)
• Primary composite endpoint: Incidence of ascites-
related complications over 180 days following
randomization
• Secondary endpoints include ascites fluid
removed over 90 days
• Timeframe: Two 28-day cycles of BIV201 therapy within
4 months, then follow patients for additional 60 days
• Currently activating 9 sites and screening patients
• 5 sites actively screening
• Patient consenting underway
• Same trial design planned for a single pivotal Phase 3
in mid-2022 with ~120 subjects
* Hepatorenal syndrome – acute kidney injury
HRS-AKI
• Planning a registrational Phase 3 trial in HRS-AKI*
‒ Based on changing serum creatinine indicate renal
function decline
‒ Expecting better outcomes because earlier
treatment is possible
‒ Expecting improved safety with continuous
infusion dosing compared to Mallinckrodt’s
CONFIRM study of terlipressin in HRS type 1
• Mallinckrodt used bolus injections (1 or 2 mg given
over approx. 5 min)
• They achieved the efficacy objective, but FDA had
safety concerns that we believe prevented approval
• Pre-IND package submitted to FDA
‒ We plan to use same PI’s, same sites, and same
drug product as our current ascites study
‒ Orphan drug designation for HRS (in addition to
ascites)
©2021 BioVie Inc.
Inflammation
9
• Inflammation is the result of the body’s natural protective processes
• If insults and pro-inflammatory cascade eliminated, pathology addressed
• If not, low grade chronic inflammation and associated insulin resistance
ensues
• Inflammation and insulin resistance go hand-in-hand
©2021 BioVie Inc.
Inflammation and disease pathology
well established in many areas
10
©2021 BioVie Inc.
NE3107: A Differentiated Molecule
11
• First-in-class molecule with desirable characteristics:
• Small molecule
• Crosses blood-brain barrier
• Excellent safety profile observed to date in pre-clinical and clinical trials
• Potential to block neuroinflammation and insulin-resistance at the right time/place in
pathologic pathway
• Does not appear to inhibit homeostatic activity
• The result of 20+ years of research that started with DHEA leading to identification of
the active metabolite that is the inhibitor of pathologic inflammation and insulin
resistance. NE3107 resulted from medical chemistry creating the molecule with
desired properties
©2021 BioVie Inc.
Extracellular Signal-Related Kinase
(ERK)
12
Critical player for both homeostasis and inflammation
(and resulting inflammation-induced insulin resistance)
ERK
Inflammatory
Pathways
via NFkB
Homeostatic Pathways
via Ras/Raf/Mek ERK
©2021 BioVie Inc.
NE3107 is Highly Selective
13
Note: NE3107 was originally known as HE3286 from Hollis-Eden Pharmaceuticals
Based on animal models:
• Blocks only inflammatory
phosphorylation of ERK by
MEK
• Breaks TNFα reactivation
cycle
• Inhibits inflammation-
reduced insulin resistance
• Does not appear to affect
ERK phosphorylation by
Ras/Raf/MEK
• No effects on homeostasis
Extra-cellular Signals
MEK MEK-P
ERK ERK-P
Perpetuates
Inflammatory
Effects
TNFα Production
NE3107
NE3107’s Potential Applicability
©2021 BioVie Inc. 14
• Reducing inflammation and insulin resistance in Alzheimer’s
Alzheimer’s Disease
• Reducing inflammation, insulin resistance in low dopamine environments
• TNF reduction reduces levodopa induced dyskinesia
Parkinson’s Disease
• MM cells secrete cytokines (eg, TNFα) and chemokines (eg, MCP-1) that stimulate
inflammation
• Targets NFkB, ERK, TNF, MCP-1, and IL-6 implicated in MM
Multiple Myeloma
• NFkB/ERK drives IL-23 and IL-6 production, leading to castrate-resistant prostate cancer
• Targets ERK-dependent IL-23 and IL-6 production and may inhibit formation of CRPC
Prostate Cancer
Catalysts & Anticiated Timelines (US)
15
2021 2022 2023 2024 2025
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Ascites
HRS-AKI
Alzheimer's
Parkinson's
Multiple
Myeoloma
Prostate Cancer
File NDA Launch
Phase 2b Phase 3
Phase 3
Phase 3* ? ?
Additional trials if required
Preclinical Phase 2 Phase 3
Preclinical Phase 2 Phase 3
Phase 1b Phase 2/3
* The FDA-authorized pivotal Phase 3 may not have enough patients for NDA approval and may require an additional study.
©2021 BioVie Inc.
Recap
16
NE3107: inhibitor of pathologic inflammation and insulin resistance with
low expected toxicity and immunosuppression. Alzheimer’s Phase 3
starting mid-2021. Parkinson’s, multiple myeloma, prostate cancer follow
BIV201: Orphan drug candidate in Phase 2b for refractory ascites; HRS-
AKI trials planned. Ascites readout anticipated in early 2022
Multiple shots on goal focused on unmet medical needs: advanced liver
disease, neurodegenerative, oncology
Capital efficient development plans with expected near-term data
readouts
©2021 BioVie Inc.
Thank You
©2021 BioVie Inc.

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BioVie Investor Deck, June 2021

  • 1. Developing Transformative Therapies to Overcome Chronic Debilitating Diseases Corporate Presentation • June, 2021 ©2021 BioVie Inc.
  • 2. Forward-looking statements 2 This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are: successful completion of the acquisition of the biopharmaceutical assets from NeurMedix Inc., BioVie’s need for, and the availability of, substantial capital in the future to fund its operations and research and development. Other risks are that BioVie’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. BioVie cannot guarantee the effectiveness of its patents or Orphan Drug designations. A more complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission. In addition to the risks described above and in BioVie’s filings with the Securities and Exchange Commission, other unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. You should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of that these slides are posted to BioVie’s website or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
  • 3. Vision for BioVie ©2021 BioVie Inc. 3 Biopharma company focused on multiple therapeutic areas with unmet medical needs • Advanced liver cirrhosis • Neurodegenerative disease • Oncologic applications
  • 4. Investment Highlights 4 NE3107: inhibitor of pathologic inflammation and insulin resistance with low expected toxicity and immunosuppression. Alzheimer’s Phase 3 starting mid-2021. Parkinson’s, multiple myeloma, prostate cancer follow BIV201: Orphan drug candidate in Phase 2b for refractory ascites; HRS- AKI trials planned. Ascites readout anticipated in early 2022 Multiple shots on goal focused on unmet medical needs: advanced liver disease, neurodegenerative, oncology Capital efficient development plans with expected near-term data readouts ©2021 BioVie Inc.
  • 5. Leadership Team 5 Cuong Do President & Chief Executive Officer • 30+ years in biopharma & technology • President, Samsung Global Strategy Group • Chief Strategy Officer for Merck • Senior partner at McKinsey & Company Jonathan Adams Liver Cirrhosis Program • 30+ years in biopharma • Founded LAT Pharma (BioVie predecessor) • Mission Pharmacal • Corbett and other healthcare agencies • Searle Pharmaceuticals J. Wendy Kim Chief Financial Officer • 35 years in finance/ accounting • As CFO managed corporate finance and operations groups • Closed M&A transactions and secured financings • Combined 22 years at KPMG and BDO LLP Chris Reading, PhD Neurodegenerative Disease Program • 40+ years in biopharma • Chief Scientific Officer, Hollis-Eden Pharmaceuticals • VP of Product and Process Dev. for Systemix • U Texas Dept. of Tumor Biology • MD Anderson Cancer Center • Over 130 peer-reviewed publications Clarence Ahlem Neurodegenerative Disease Program • 35+ years in biopharma • Vice President, Product Development Harbor Therapeutics • Director, Product Development, Hollis- Eden Pharmaceuticals • SyStemix • Hybritech • US San Diego ©2021 BioVie Inc.
  • 6. Disease Target: Refractory Ascites ©2021 BioVie Inc. 6 6 * TIPS = transjugular intrahepatic portosystemic shunt to channel blood flow around the liver Our first disease target is ascites, the accumulation of 5+ liters of fluid in the abdomen. Refractory ascites patients typically undergo paracentesis to remove ascites fluid every week to 10 days Paracentesis: • Withdrawal of 5–10L of ascites fluid (on average) from abdomen using a large bore needle • Provides a few days of symptomatic relief • The kidneys are “burning out” by retaining massive quantities of salt and water • Patients suffer frequent life-threatening complications • No remaining options except for TIPS* surgery or liver transplant • Estimated $670 million addressable US market with 20,000 targeted patients • No drugs ever approved by FDA to treat ascites
  • 7. Novel Prefilled Syringe with Patent-pending Liquid Formulation 7 • Global PCT filed to protect our novel liquid formulation • Accurate dosing: Eliminates mixing minute quantities of powder terlipressin that could result in medication errors or sterility loss • Enhanced convenience: Simply inject fluid into the saline bag and attach to pump BIV201 Prefilled Syringe Stable for 12+months at room temp. Needle or Connector 50 mL bag of saline for insertion into pump Portable pump Carried in small satchel ©2021 BioVie Inc.
  • 8. BIV201 Development Plans 8 Ascites • Revised Phase 2b protocol and CMC package covering prefilled syringe cleared by FDA • 20 to receive BIV201 therapy + standard of care (SOC); 10 to receive SOC only (control group) • Primary composite endpoint: Incidence of ascites- related complications over 180 days following randomization • Secondary endpoints include ascites fluid removed over 90 days • Timeframe: Two 28-day cycles of BIV201 therapy within 4 months, then follow patients for additional 60 days • Currently activating 9 sites and screening patients • 5 sites actively screening • Patient consenting underway • Same trial design planned for a single pivotal Phase 3 in mid-2022 with ~120 subjects * Hepatorenal syndrome – acute kidney injury HRS-AKI • Planning a registrational Phase 3 trial in HRS-AKI* ‒ Based on changing serum creatinine indicate renal function decline ‒ Expecting better outcomes because earlier treatment is possible ‒ Expecting improved safety with continuous infusion dosing compared to Mallinckrodt’s CONFIRM study of terlipressin in HRS type 1 • Mallinckrodt used bolus injections (1 or 2 mg given over approx. 5 min) • They achieved the efficacy objective, but FDA had safety concerns that we believe prevented approval • Pre-IND package submitted to FDA ‒ We plan to use same PI’s, same sites, and same drug product as our current ascites study ‒ Orphan drug designation for HRS (in addition to ascites) ©2021 BioVie Inc.
  • 9. Inflammation 9 • Inflammation is the result of the body’s natural protective processes • If insults and pro-inflammatory cascade eliminated, pathology addressed • If not, low grade chronic inflammation and associated insulin resistance ensues • Inflammation and insulin resistance go hand-in-hand ©2021 BioVie Inc.
  • 10. Inflammation and disease pathology well established in many areas 10 ©2021 BioVie Inc.
  • 11. NE3107: A Differentiated Molecule 11 • First-in-class molecule with desirable characteristics: • Small molecule • Crosses blood-brain barrier • Excellent safety profile observed to date in pre-clinical and clinical trials • Potential to block neuroinflammation and insulin-resistance at the right time/place in pathologic pathway • Does not appear to inhibit homeostatic activity • The result of 20+ years of research that started with DHEA leading to identification of the active metabolite that is the inhibitor of pathologic inflammation and insulin resistance. NE3107 resulted from medical chemistry creating the molecule with desired properties ©2021 BioVie Inc.
  • 12. Extracellular Signal-Related Kinase (ERK) 12 Critical player for both homeostasis and inflammation (and resulting inflammation-induced insulin resistance) ERK Inflammatory Pathways via NFkB Homeostatic Pathways via Ras/Raf/Mek ERK ©2021 BioVie Inc.
  • 13. NE3107 is Highly Selective 13 Note: NE3107 was originally known as HE3286 from Hollis-Eden Pharmaceuticals Based on animal models: • Blocks only inflammatory phosphorylation of ERK by MEK • Breaks TNFα reactivation cycle • Inhibits inflammation- reduced insulin resistance • Does not appear to affect ERK phosphorylation by Ras/Raf/MEK • No effects on homeostasis Extra-cellular Signals MEK MEK-P ERK ERK-P Perpetuates Inflammatory Effects TNFα Production NE3107
  • 14. NE3107’s Potential Applicability ©2021 BioVie Inc. 14 • Reducing inflammation and insulin resistance in Alzheimer’s Alzheimer’s Disease • Reducing inflammation, insulin resistance in low dopamine environments • TNF reduction reduces levodopa induced dyskinesia Parkinson’s Disease • MM cells secrete cytokines (eg, TNFα) and chemokines (eg, MCP-1) that stimulate inflammation • Targets NFkB, ERK, TNF, MCP-1, and IL-6 implicated in MM Multiple Myeloma • NFkB/ERK drives IL-23 and IL-6 production, leading to castrate-resistant prostate cancer • Targets ERK-dependent IL-23 and IL-6 production and may inhibit formation of CRPC Prostate Cancer
  • 15. Catalysts & Anticiated Timelines (US) 15 2021 2022 2023 2024 2025 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Ascites HRS-AKI Alzheimer's Parkinson's Multiple Myeoloma Prostate Cancer File NDA Launch Phase 2b Phase 3 Phase 3 Phase 3* ? ? Additional trials if required Preclinical Phase 2 Phase 3 Preclinical Phase 2 Phase 3 Phase 1b Phase 2/3 * The FDA-authorized pivotal Phase 3 may not have enough patients for NDA approval and may require an additional study. ©2021 BioVie Inc.
  • 16. Recap 16 NE3107: inhibitor of pathologic inflammation and insulin resistance with low expected toxicity and immunosuppression. Alzheimer’s Phase 3 starting mid-2021. Parkinson’s, multiple myeloma, prostate cancer follow BIV201: Orphan drug candidate in Phase 2b for refractory ascites; HRS- AKI trials planned. Ascites readout anticipated in early 2022 Multiple shots on goal focused on unmet medical needs: advanced liver disease, neurodegenerative, oncology Capital efficient development plans with expected near-term data readouts ©2021 BioVie Inc.