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BioVie Investor Deck, Novmber 2020


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BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
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BioVie Investor Deck, Novmber 2020

  1. 1. 1 Pioneering Therapies for Patients Suffering from Advanced Liver Cirrhosis Corporate Presentation | November 2020
  2. 2. 2 Forward-looking statements 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 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. 3. 3 $670M 20,000 US patients targeted for BIV201 therapy 0/0 Number of FDA- approved drugs to specifically treat ascites; Number of direct competitors Phase 2; Ph3 in 2021 Mid-stage Phase 2 Orphan drug candidate; FDA Fast Track and will seek Breakthrough Therapy status Orphan Drug Orphan Drug designations for ascites and HRS with potential 7 years market exclusivity**; Patent- pending liquid formulations BioVie Overview Addressable US ascites market size*; Projected BIV201 US peak sales of $450 M with 67% penetration Sources/Notes: * D'Amico 2014; BioVie poster presentation at AASLD 2019. Assumes three 28-day treatment regimens annually. ** If first to market.
  4. 4. 4 Our initial target is ascites due to advanced liver cirrhosis • Cirrhosis is the 11th leading cause of death in the US1 • Resulted in 42,000 US deaths in 20171 • Ascites is the most common major complication2 • For refractory ascites the mean one-year survival rate is only 50%3 Our first disease target is ascites, the accumulation of 5+ liters of fluid in the abdomen. Fluid in the peritoneal cavity (ASCITES) 1CDC National Vital Statistics Report, 2017 Data 2Ge and Runyon 2016 3Bureau et al. 2017
  5. 5. 5 No effective medication options: Primed for disruption No drugs approved by FDA specifically for treating ascites Refractory ascites patients have frequent paracentesis procedures: • Withdrawal of ~5–10L of ascites fluid from abdomen every week to 10 days with a large bore needle* • Provides short-term relief, but the kidneys will eventually “burn out” • Patients worsen with life-threatening complications • No remaining options except for TIPS** surgery or liver transplant * Wong 2012 ** TIPS = transjugular intrahepatic portosystemic shunt to channel blood flow around the liver
  6. 6. 6 Ascites patients incur $5 billion+ in annual treatment costs Sources: HCUP Nationwide Readmissions Database 2016: Average length of stay and charges for patients requiring paracentesis; BioVie poster presentation at AASLD 2019.
  7. 7. 7 How our therapy is intended to work: • Vasoconstricts the central region, forcing blood flow through the liver • This restores effective blood volume in the arteries, which • Shuts down the RAAS signaling pathway, so the kidneys no longer retain excessive salt and water • Thereby halting ascites fluid production Therapeutic goal: Halt the downward spiral Adapted from: Wong 2012
  8. 8. 8 Exploring the potential for terlipressin Terlipressin is approved in 40+ countries for treating two related complications of liver cirrhosis: HRS & BEV1 • Used for decades in hospitals dosed by IV bolus injection (1-2 mg every 4-6 hours) • Well understood mechanism of action2 with hundreds of publications • Not approved in the US or Japan • Not yet approved to treat ascites in any country BioVie advisor Dr. Paolo Angeli invented a new dosing method as a continuous infusion in the outpatient setting 1. HRS = Hepatorenal syndrome; BEV = Bleeding esophageal varices 2. Ding 2013
  9. 9. 9 BIV201 clinical development program BIV201 key clinical objectives are to: • Reduce ascites fluid accumulation and related complications requiring hospitalization • Deliver terlipressin safely via continuous infusion with a portable pump and our novel patent-pending liquid formulation in a pre-filled syringe • Enable safe at-home therapy • Provide a long-term bridge to liver transplant, or potentially avoid the need for transplant* Continuous infusion dosing: a new treatment paradigm “Terlipressin given by continuous infusion is better tolerated than intravenous boluses in the treatment of type 1 HRS. Moreover, it is effective at lower doses**” BIV201 is an investigational therapy BIV201 ** HEPATOLOGY 2016;63:983-992. * Based on Australian study results; will require US clinical trials to support this use.
  10. 10. 1010 Retrospective study results from P.Angeli, MD (Italy 2015) Continuous infusion terlipressin in 6 refractory ascites/HRS patients Source: Adapted from BioVie US Patent application 16/379,446 Angeli et al. No drug-related side effects were reported in this study. Terlipressin is not available in the US
  11. 11. 11 Prospective study by Chapman et al. (Australia 2018) Continuous infusion terlipressin in 19 refractory ascites/HRS patients Pre-therapy: • 70% of patients required weekly large volume paracentesis (LVP) • 63% poor muscle strength Results: • Median duration of CI terlipressin treatment: 51 days • 46% average reduction in frequency of paracentesis • Significantly improved muscle strength and nutritional intake • No complications directly attributable to terlipressin Decreased Need for Paracentesis Change in frequency of paracentesis procedures Source: JHEP 2019. Terlipressin is not available in the US
  12. 12. 12 BIV201 Phase 2a study results in 6 refractory ascites patients (completed April 2019) Principal Investigator: Jasmohan Bajaj, MD at McGuire VA in Richmond, VA Primary objectives to assess safety, tolerability and pharmacokinetics (PK) Results1: • Pharmacokinetics (PK) of continuous terlipressin infusion matched our predicted model2 • Serious complications observed over 2-month period during/after BIV201 therapy: • Recurrence of hepatic encephalopathy (HE): 1 patient – possibly due to dehydration in conjunction with strong response to terlipressin in conjunction with diuretics (protocol modified to avoid this) • Leaking umbilical hernia: 1 patient (pre-existing) – not drug-related • Other adverse events observed: bacteremia3, asymptomatic hyponatremia, abdominal pain, headache, diarrhea, dizziness • BIV201 therapy maintained for 28 days in 3 of 6 patients 1. Large-scale clinical trial(s) will be required to confirm results. 2. Source: BioVie poster presentation at AASLD 2019. 3. On day 28 possibly related to a chronic non-healing leg ulcer wound (one patient).
  13. 13. 13 BioVie Phase 2a trial results: Timing of next paracenteses procedure 4 of 6 patients achieved ≥ 50% increase in days until next ascites fluid withdrawal (paracentesis) after starting BIV201 therapy Source: BioVie poster presentation at AASLD 2019. BIV201 is an investigational therapy
  14. 14. 14 BioVie Phase 2a trial results: Change in serum creatinine 4 of 6 patients experienced a reduction in serum creatinine (clearance of SCr is an indicator of kidney function) Source: BioVie poster presentation at AASLD 2019. BIV201 is an investigational therapy
  15. 15. 15 Advancing the BIV201 clinical program • June 2019: Type C Guidance Meeting with FDA • July: FDA meeting minutes received • October: Submitted Phase 2b/3 Clinical Trial Protocol to FDA • April/May 2020: FDA final feedback received and trial design modified • Clinical study plan: A Phase 2 Randomized, Dose-Titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 Compared to Standard of Care to Reduce Ascites and Complications in Cirrhotic Patients With Refractory Ascites ( NCT identifier 04112199) • May 2020: FDA CMC Division clearance to use new prefilled syringe in the Phase 2 trial (subject to additional standard tests)
  16. 16. 16 Phase 2 & 3 clinical trial plan • US Phase 2 trial with 24 refractory ascites patients: ‒ 16 will receive BIV201 + standard of care (SOC); 8 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 ‒ Enrollment: 4-6 sites will enroll ~5 subjects each ‒ Timeframe: Two 28-day cycles BIV201 within 4 months and follow patients for 60 days • Following the Phase 2, planning a single pivotal US Phase 3 clinical trial ‒ Expect similar design to Phase 2 trial ‒ Planning ~120 patients at ~20 study sites Source: (identifier: NCT04112199). The FDA provided additional guidance in April 2020; validation of quality of life measures will be explored in Phase 2 trial.
  17. 17. 17 BIV201 is an investigational therapy BIV201 projected clinical timeline Phase 2a Trial + PK Analysis Completed April 2019 Phase 2 & 3 Clinical Trials YE/2018 YE/2020 YE/2021 Begin Phase 2 Target NDA*Filing 2022 * New Drug Application YE/2019 BIV201 is an investigational therapy
  18. 18. 18 Novel BIV201 home care delivery system BIV201 Prefilled Syringe Stable for 9+months at room temp. Needle-free Connector 50 mL bag of saline for insertion into pump Portable pump Carried in small satchel
  19. 19. 19 Will seek patent coverage in Japan, Europe, and China US Orphan Drug designations for both ascites (Sept ‘16) and HRS (Nov ‘18) to enable up to 7 years of market exclusivity FDA Fast Track status; will seek Breakthrough Therapy designation FDA Creating global patent estate to cover proprietary liquid terlipressin formulations USPTO IP protection and FDA Fast Track status
  20. 20. 20 Estimated US Patients (000s) Total Addressable Market (TAM) Projected Peak US Sales Refractory Ascites 20.01 $670 M $450 M Bleeding Esophageal Varices (BEV) 6.63 $166 M $83 M Catecholamine-Resistant Hypotension/Sepsis/Shock 125,0002 $150 M $75 M Hepatorenal Syndrome (HRS) 16.83 $67 M $34 M TOTAL: $642 MSources/Notes: 1. D'Amico 2014; Gines 2004 2. Third party market assessment, published 2015 3. US Patient Hospital Discharge Data, 2016; BioVie poster presentation at AASLD 2019. BIV201 revenue potential – US only
  21. 21. 21 Will Seek Patent Coverage Patients Diagnosed with Cirrhosis Estimated Ascites Patients (000s) Est’d Refractory/ Intractable Ascites (000s) Japan 270,0001 541 10.8 Europe 800,0002 164 33 China 2 million3 500 100 Sources/Notes: 1. Third party market assessment, published 2013 2. BioVie assessment based on multiple sources 3. Minimum based on reported prevalence rates of cirrhosis in US/EU (China has highest prevalence of Hepatitis B worldwide) BIV201 international ascites treatment opportunity Potential to increase BIV201 revenues by >2X (excluding China) ✓ ✓ ✓
  22. 22. 22 Experienced and effective management team Terren Peizer, Chief Executive Officer, Chairman of the Board Mr. Peizer is an entrepreneur, investor, and financier with a particular interest in healthcare, having founded and successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a leader in behavioral and mental health management services. He has served as the Chairman of the Board of Directors and CEO of Catasys since inception in 2004. Mr. Peizer is the Founder, Chairman, CEO and majority shareholder of NeurMedix, Inc., a biotechnology company with a focus on inflammatory, neurological and neuro-degenerative diseases. He is also the Chairman of Acuitas Group Holdings, LLC, his personal holding company that owns all his portfolio company interests, including BioVie, NeurMedix and Catasys. Acuitas is an industry leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into portfolio companies. Previously he was Chairman of Cray, Inc., the leading supercomputing company, and held senior executive positions with the investment banking firms Goldman Sachs, First Boston, and Drexel Burnham Lambert. He received his B.S.E. in finance from The Wharton School of Finance and Commerce. Jonathan Adams, President & Chief Operating Officer Founded the predecessor company to BioVie with over 30 years of biopharma industry experience including finance, M&A and licensing deals, technology commercialization, global product launches, and sales force management. Mr. Adams was a member of Searle Pharma’s global launch team for Celebrex and worked on the commercialization of follow-on COX-2 inhibitors. After Searle was acquired, he worked in account management for healthcare advertising agencies and assisted with launching drugs and medical devices in a wide range of therapeutic areas. Subsequently he became a leader of Mission Pharmacal’s urology division. Mr. Adams earned a BS at Cornell University and an MBA at the Tuck School at Dartmouth.
  23. 23. 23 Experienced and effective clinical team Penelope Markham, PhD, Chief Scientific Officer Dr. Markham led the development of modified terlipressin compounds for LAT Pharma LLC, the predecessor company to BioVie, for 7 years prior to its acquisition by BioVie. Previously, she spent 15 years in immunology, infectious disease, bacteriology and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx, Inc. engaged in antibiotic drug discovery. Former member of NIH grant review panels and consulted in wide array of therapeutic areas including Orphan drugs. Dr. Markham has more than 20 publications and three patents. Giacomo Basadonna, MD, PhD Acting Chief Medical Officer A renowned transplant surgeon, Dr. Basadonna is a member of 23 national committees and 14 professional societies. Prior to joining Alira Health Clinical CRO as chief medical officer, Dr. Basadonna’s appointments included UC Davis Medical Center, Yale New Haven Hospital, and UMass Memorial Hospital. He has over 80 publications in peer-reviewed journals. Denise Smith, MS, Vice President of Manufacturing Managed the development laboratory for a large CMO, including analytical development and validation, and established manufacturing processes for parenteral products (liquid, lyophilized, liposomes, emulsions) for new chemical entities for the National Cancer Institute and other contract customers. Susan Clausen, PhD, Clinical Development and Regulatory Affairs Consultant With a proven track record defining clinical and regulatory strategies for drug development and tactical implementation, Dr. Clausen has made key contributions to many successful new drug approval (NDA) applications. Dr. Clausen has over 20 years experience in drug development having consulted for pharmaceutical companies and held senior clinical development and regulatory positions at Middlebrook Pharmaceuticals and Shire. J. Wendy Kim, CPA, Chief Financial Officer Over 25 years of experience in accounting and finance. As a CFO she managed corporate finance and operational groups, closed M&A transactions and secured bank financings.
  24. 24. 24 Accomplished Board of Directors Steve Gorlin Founded many biopharma companies including Hycor Biomedical, Theragenics, Medicis Pharmaceutical, EntreMed, MRI Interventions, DARA BioSciences, MiMedx, Medivation (sold to Pfizer for $14 billion) and NantKwest. Mr. Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical Engineering Advisory Board. He is currently a member of the Research Institute Advisory Committee (RIAC) of Massachusetts General Hospital. He started The Touch Foundation, a nonprofit organization for the blind, and was a principal contributor to Camp Kudzu for diabetic children. Bob Hariri, MD, PhD Chairman, founder, and CEO of Celularity, Inc., a leading cellular therapeutics company. He was the founder and CEO of Anthrogenesis Corporation, and after its acquisition served as CEO of Celgene Cellular Therapeutics. Dr. Hariri co- founded the genomic health intelligence company, Human Longevity, Inc. Dr. Hariri pioneered the use of stem cells to treat a range of life-threatening human diseases. He is widely acknowledged for his discovery of pluripotent stem cells and for assisting with discovering the physiological activities of tumor necrosis factor (TNF). He holds over 170 issued and pending patents and has authored over 150 publications. Cuong Do President, Samsung Global Strategy Group. Mr. Do helps to set the strategic direction for Samsung Group’s diverse business portfolio. He was previously the Chief Strategy Officer for Merck from October 2011 to March 2014, Tyco Electronics, and Lenovo. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices. He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.
  25. 25. 25 Accomplished Board of Directors Michael Sherman Former managing director at Barclays and Lehman Brothers; significant experience in health care finance; previously a securities attorney. Richard J Berman Former Chairman of National Investment Managers with $12 billion pension administration assets; director of Catasys, Inc., Advaxis, Inc., Cryoport Inc. and Immuron Ltd. Previously started the M&A and Leveraged Buyout Departments for Bankers Trust Company. Jim Lang Founder and CEO of EVERSANA, now the leading provider of global commercialization services to the life science industry. Former CEO of healthcare analytics firm Decision Resources Group; provided investment and guided the development of multiple healthcare companies. Sig Rogich CEO of President of The Rogich Communications Group and serves on the Board of Keep Memory Alive, which raises awareness about brain disorders and Alzheimer's disease. He was formerly the US Ambassador to Iceland and served as a senior consultant to Presidents Ronald Reagan and George H.W. Bush.
  26. 26. 26 World-leading medical advisory team Paolo Angeli, MD Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University of Padova, Italy. He has participated in more than 15 clinical trials (Phase II – IV) in the treatment of clinical complications of portal hypertension and liver transplant. Currently he is Secretary of the International Ascites Club and, as a member of EASL, has participated in drafting guidelines for the management of patients with cirrhosis and ascites. Dr. Angeli has pioneered the use of continuous infusion terlipressin as a safer alternative to the traditional approach of intermitted IV bolus dosing in the treatment of hepatorenal syndrome. He is a frequent speaker on liver disease and has been widely published. Lead medical advisor Other key medical advisors include US and global liver cirrhosis experts
  27. 27. 2728 Company highlights • BIV201 is a novel therapeutic approach to a severe unmet medical need • Mid-stage drug candidate in US development for ascites - No drugs ever approved by FDA to treat ascites - Similar therapy currently in practice in Australia* • Clinical development plan: - Commence US Phase 2 clinical study by end of 2020 - Commence pivotal Phase 3 trial in 2021 - Submit NDA for US marketing approval in 2022 • IP estate includes two Orphan drug designations and formulation patent application • High cost of patient care creates strong economic rationale for drug therapy • $450 million ascites sales opportunity in US alone • Additional revenue opportunities for related conditions and global expansion * Source: ABC News Australia, March 5, 2018
  28. 28. 28 Pioneering Therapies for Patients Suffering from Advanced Liver Cirrhosis Corporate Presentation