BioVie Pitch Deck (2020): 28-Slide Breakdown

BioVie’s September 2020 investor deck is a clinical-heavy presentation focused on BIV201, a therapy for refractory ascites resulting from advanced liver cirrhosis. The company highlights that cirrhosis is the 11th leading cause of death in the US, with a 50% one-year survival rate for those with refractory ascites. The deck anchors its value proposition on Phase 2a trial results, where 4 of 6 patients saw a 50% or greater increase in time between paracentesis procedures. With US Orphan Drug designations and FDA Fast Track status, the company outlines a clear regulatory path toward a pivotal P…

Key takeaways

• Cirrhosis is cited as the 11th leading cause of death in the US, resulting in 42,000 deaths in 2017 (Slide 4).
• Refractory ascites carries a mean one-year survival rate of only 50% (Slide 4).
• Retrospective study results for continuous infusion terlipressin showed a 55% decrease in mean ascites fluid and a 47% improvement in renal function (Slide 10).
• Phase 2a trial results demonstrated that 4 of 6 patients achieved a 50% or greater increase in days until the next paracentesis (Slide 13).
• The planned US Phase 2 trial involves 24 patients, with 16 receiving BIV201 plus standard of care (Slide 16).
• BioVie holds US Orphan Drug designations for both ascites (Sept '16) and HRS (Nov '18), providing up to 7 years of market exclusivity (Slide 19).
• The company has secured FDA Fast Track status and intends to seek Breakthrough Therapy designation (Slide 19).
• The management team is led by CEO Terren Peizer, who has founded healthcare companies and managed over $1.2 billion in investments (Slide 22).

Frequently asked questions

What is the primary medical condition BioVie is targeting?

BioVie is targeting ascites, which is the accumulation of 5+ liters of fluid in the abdomen, caused by advanced liver cirrhosis. According to slide 4, cirrhosis was the 11th leading cause of death in the US in 2017, and refractory ascites has a very poor prognosis with only a 50% one-year survival rate.

What clinical evidence does the deck provide for their therapy?

The deck provides two main data points: a retrospective study from 2015 showing a 55% reduction in ascites fluid (Slide 10), and their own Phase 2a trial results. In the Phase 2a trial, 4 out of 6 patients experienced a 50% or greater increase in the time between fluid withdrawal procedures (Slide 13).

What is the regulatory status of BioVie's lead candidate?

As of September 2020, BioVie had secured US Orphan Drug designations for both ascites and Hepatorenal Syndrome (HRS), which grants 7 years of market exclusivity. They also have FDA Fast Track status and stated intentions to seek a Breakthrough Therapy designation (Slide 19).

What does the clinical trial roadmap look like?

Slide 16 outlines a US Phase 2 trial with 24 patients (16 treatment, 8 control) across 4-6 sites. Following this, the company plans a single pivotal US Phase 3 clinical trial involving approximately 120 patients at roughly 20 study sites, mirroring the Phase 2 design.

Who are the key members of the leadership team?

The team is led by CEO and Chairman Terren Peizer, an entrepreneur and financier who founded Catasys and NeurMedix. President and COO Jonathan Adams brings 30 years of biopharma experience, including work on the global launch of Celebrex at Searle Pharma (Slide 22).

BioVie pitch deck: the facts

Company

BioVie

Year

2020

Stage

Clinical Stage (Phase 2)

Slides

28

Sector

Biotechnology / Pharmaceuticals

Deck type

Investor Deck

Outcome

Publicly Traded (BIVI)

Headquarters

United States

BioVie pitch deck PDF

The full BioVie deck is embedded on this page and can be read slide by slide in the browser — no download or account required. Each slide is covered in the breakdown above.

What the BioVie Inc. pitch deck was used for

This deck is BioVie Inc.’s **September 2020 corporate / investor presentation** for its liver cirrhosis and ascites program BIV201, a continuous infusion terlipressin therapy in Phase 2 clinical development. It was prepared around the time of BioVie’s **September 2020 Nasdaq follow-on/public offering of common stock**, in which the company raised approximately **$18 million** and uplisted to Nasdaq. The presentation emphasizes BioVie’s position as a clinical-stage company targeting refractory ascites, highlighting Orphan Drug and FDA Fast Track designations for BIV201 and outlining plans for a Phase 2 study followed by a pivotal Phase 3 trial. The deck targets public-market and institutional investors evaluating participation in BioVie’s 2020 equity raise and ongoing funding needs for BIV201’s late-stage development.

Business model: Publicly traded clinical-stage biopharmaceutical company developing therapies for serious liver disease complications (notably ascites due to advanced liver cirrhosis) and, in later years, neurological disorders.

Year

2020

Headquarters

Carson City, Nevada, United States.

Industry

Biotechnology / Pharmaceuticals.

Round: Registered public offering / follow-on equity raise associated with Nasdaq listing.

Raised: Approximately $18 million gross proceeds from a registered public offering / follow-on of common stock completed in September 2020.

Use of funds as presented: According to company filings, the September 2020 offering proceeds were used in part to satisfy approximately $1.8 million owed under a debenture held by controlling stockholder Acuitas and to fund BIV201 clinical development and general corporate purposes.

What happened after the BioVie Inc. deck

The September 2020 deck supported BioVie’s successful ~$18 million Nasdaq public offering and outlined a development plan for BIV201 in ascites, which subsequently progressed through Phase 2 and regulatory interactions with FDA but encountered a terminated Phase 2b trial and a strategic shift toward seeking a partner for Phase 3 rather than independently advancing to commercialization.

• On September 23, 2020, BioVie announced the closing of a registered public offering of common stock raising approximatel
• By June 2020, prior to the deck, BioVie had completed a Phase 2 clinical protocol for BIV201 (trial identifier NCT041121
• BIV201 obtained **Orphan Drug** designations for ascites and hepatorenal syndrome and **FDA Fast Track** status, and by
• In March 2024, BioVie disclosed that it had **terminated a Phase 2b trial** in refractory ascites after enrolling about

What the BioVie Inc. deck got right

• Clear articulation of unmet medical need. The deck addresses a **well-defined unmet need** in ascites due to advanced liver cirrhosis, emphasizing that no FDA-approved drugs specifically treat ascites and that current management relies on frequent paracentesis, TIPS, or transplant, supporting a strong problem statement.
• Strong mechanistic story linked to clinical pathophysiology. BioVie presents a **mechanistically coherent therapeutic hypothesis**: continuous infusion terlipressin (BIV201) aims to vasoconstrict the splanchnic circulation, restore effective arterial blood volume, shut down RAAS activation, and thereby halt ascites fluid production, which is clearly explained in the deck’s schematic on how ascites develops and how the therapy works.
• Regulatory validation and defined development roadmap. The deck highlights **Orphan Drug and FDA Fast Track designations** and a defined development path (randomized Phase 2 followed by a pivotal Phase 3 with potential for a single registrational trial), providing regulatory validation and a credible roadmap for investors.
• Integration of health-economic evidence. Inclusion of **healthcare utilization and cost data**—such as hospitalization counts, 30-day readmissions, and average length of stay and charges for patients requiring paracentesis—demonstrates potential health-economic benefits and supports future reimbursement discussions.
• Tight linkage between story and contemporaneous financing event. The deck is closely aligned with a **specific capital markets event**—the September 2020 ~$18 million public offering and Nasdaq uplisting—offering investors timely context on the company’s stage, financing strategy, and immediate milestones to be funded.
• Consistency between 2020 narrative and subsequent development steps. Subsequent corporate communications show that the core claims in the deck (BIV201’s Orphan/Fast Track status, focus on ascites, and planned Phase 2/3 progression) were followed by concrete actions (Phase 2b initiation, FDA feedback on Phase 3), indicating **consistency between the deck narrative and later execution**, even though the path included a terminated Phase 2b trial.

What could have been stronger

• Heavy reliance on early-stage data and mechanistic story. The deck relies primarily on **Phase 2a / early-stage clinical data** and mechanistic rationale without presenting robust randomized controlled data or long-term outcomes; later company communications indicate that the Phase 2b trial was terminated after enrolling only about half of the intended patients, which is not visible from the 2020 deck.
• Limited transparency on market-access assumptions in the deck itself. While the deck quantifies hospitalization rates, readmissions, and treatment costs for ascites, it does not clearly detail the **size of the target reimbursable population, pricing assumptions, or payer dynamics**, even though later corporate materials describe a target market of about 20,000 U.S. patients and projected peak sales.
• Regulatory, safety, and competitive risks underdeveloped. The deck emphasizes Orphan Drug and Fast Track designations and a path to Phase 3 but provides **limited detail on regulatory risks, competition (e.g., other terlipressin uses), or potential safety concerns**, despite terlipressin being a vasoactive agent with known hemodynamic effects.
• Insufficient breakdown of proceeds and milestones for the raise. Although the deck is used around a public offering, it does not explicitly break down **funds use by milestone** (e.g., allocation to Phase 2 versus Phase 3, manufacturing scale-up, or CMC work), whereas SEC filings refer to using offering proceeds to repay debt and fund clinical programs.

How an investor would read this deck

What draws attention

• The deck’s timing aligns with BioVie’s **September 2020 public offering / follow-on of common stock** that raised about $18 million and facilitated a Nasdaq listing, so investors will scrutinize how those proceeds were allocated and what milestones were achieved.
• Investors will focus on **BIV201’s differentiation** versus existing terlipressin uses and supportive care for ascites, including whether continuous infusion provides clinically meaningful and economically justifiable advantages over current practice (paracentesis, TIPS, transplant).
• The presence of **Orphan Drug and Fast Track designations** and FDA feedback on Phase 3 design is a positive regulatory signal, but investors will want to understand the implications of the terminated Phase 2b trial and the need for a partner for Phase 3.
• Since BioVie later expanded into neurology (e.g., Alzheimer’s and Parkinson’s programs), investors will assess **capital allocation** between liver and neuro programs and whether the 2020 liver-focused raise built sufficient value prior to shifting strategic focus.

Risks that stand out

• The **Phase 2b trial termination** and need for a partner for Phase 3 introduce execution risk and suggest potential challenges in trial enrollment, operational capacity, or strategic prioritization.
• Regulatory approval risk remains significant, as BIV201 has not yet completed Phase 3, and the company will have to demonstrate not only efficacy in reducing ascites but also improvements in clinically meaningful outcomes such as hospitalization, renal function, and survival.
• The ascites market, while underserved and potentially attractive under Orphan Drug incentives, may face **reimbursement and pricing constraints**, particularly if payers view BIV201 as marginally incremental to existing terlipressin use or procedural interventions.
• BioVie’s later diversification into neurology programs adds **portfolio complexity and capital allocation risk**, which could dilute focus and resources away from the liver portfolio initiated in this deck.

Questions this deck invites

• How were the approximately **$18 million** in proceeds from the September 2020 public offering allocated among BIV201 clinical development, manufacturing, regulatory work, debt repayment, and corporate overhead, and which milestones were di
• What were the **design, endpoints, and outcomes** of the Phase 2a and initiated Phase 2b trials (including responder rates, safety, and quality-of-life measures), and how do these compare to standard of care (paracentesis, TIPS)?
• What specific **FDA feedback** guided the Phase 3 trial design for BIV201, and how does that feedback affect the probability of a single Phase 3 study being sufficient for approval in ascites due to liver cirrhosis?
• Why was the **Phase 2b refractory ascites trial terminated** after enrolling about half of planned patients, and how do those data influence the risk–benefit assessment and positioning of BIV201 in an earlier disease stage as later describe
• Given that BIV201 uses terlipressin, which is already approved for related complications of advanced liver cirrhosis, how strong is BioVie’s **IP and exclusivity position** around continuous infusion delivery, and what is the expected durat

What founders can take from the BioVie Inc. deck

• A deck that clearly ties an **unmet clinical need** (no FDA-approved ascites drugs, high hospitalization and readmission rates) to a concrete mechanistic solution (continuous infusion terlipressin restoring effective blood volume and reducing RAAS activation) can create a compelling narrative for in
• Explicit mention of **regulatory advantages** such as Orphan Drug and Fast Track designations helps frame a de-risked regulatory path and potential for expedited development, which can be pivotal in justifying a Phase 2-to-Phase 3 transition raise.
• Aligning an investor deck with a **specific capital markets transaction** (in this case, a Nasdaq public offering of ~ $18 million) provides context and urgency, showing investors exactly what stage the company is at and how proceeds will be applied.
• Using **health-economic data** (e.g., hospitalization frequency, readmission rates, and treatment costs) strengthens the argument for payer and health system value, not just clinical benefit, which is particularly important in chronic, high-cost indications like ascites.
• Relying heavily on early clinical data and mechanistic rationale in the deck, without anticipating later challenges like a terminated Phase 2b trial, illustrates the importance of transparently addressing **development risk and contingency plans** to maintain investor trust over time.
• Maintaining consistency across investor decks over time (September 2020 and later 2020–2021 decks) in describing the lead asset, regulatory status, and trial plans helps investors track progress, but subsequent events (e.g., trial termination, pipeline reprioritization) highlight the need to **conti

BioVie Inc. pitch deck: common questions

What does BioVie do?

BioVie Inc. is a **clinical-stage biopharmaceutical company** developing BIV201, a continuous infusion formulation of terlipressin, for the treatment of **ascites due to advanced liver cirrhosis**, including refractory ascites where patients undergo frequent paracentesis and have limited treatment options.

What is the focus of BioVie’s September 2020 investor deck?

This deck is the **September 2020 corporate / investor presentation** for BioVie Inc., focused on its lead program BIV201 for ascites in advanced liver cirrhosis, and was used in the context of the company’s 2020 Nasdaq public offering and related investor outreach.

What fundraise was this 2020 BioVie deck associated with?

BioVie’s September 2020 deck supports a **registered public offering / follow-on equity raise of approximately $18 million**, which enabled the company to uplist to Nasdaq and fund development of BIV201, including a planned randomized Phase 2 study and a pivotal Phase 3 trial.

What problem and unmet need does BioVie’s 2020 deck emphasize?

The deck highlights that **no FDA-approved drugs** existed specifically for the treatment of ascites in advanced liver cirrhosis; patients often rely on repeated large-volume paracentesis, TIPS surgery, or liver transplant, with high hospitalization and readmission rates and significant costs. BioVie positions BIV201 as a novel continuous infusion terlipressin therapy designed to restore effective blood volume, reduce RAAS activation, and halt ascites fluid production.

What happened with BIV201 after the 2020 deck?

According to later company disclosures, BIV201 obtained **Orphan Drug** designations for ascites and hepatorenal syndrome and received **FDA Fast Track** status, and BioVie completed a Phase 2 program and worked with FDA to design a Phase 3 trial. In 2024, BioVie reported that it terminated a Phase 2b study for refractory ascites after enrolling about half of the intended patients, though data from treated patients suggested more than a 50% reduction in ascites fluid buildup, and the company indicated it would seek a partner for Phase 3.

Sources

Funding and outcome facts on this page were researched on 2026-08-21 from the pages below.

• BioVie Announces Closing of Public Offering of Common Stock
• BioVie Investor Deck, September 2020
• BioVie Investor Deck, May 2021
• BioVie Investor Deck, November 2020
• BioVie Investor Deck, June 2021 | PDF - Slideshare
• BioVie Investor Deck, February 2021
• BioVie Investor Deck, March 2021
• BioVie Announces Pipeline Update and Near-Term Clinical Priorities

BioVie pitch deck slides

What each slide of the BioVie pitch deck says

Slide 1

f= i - — “-. - — — = Ee Pioneering Therapies for Patients Suffering from.,Advanced Liver Cirrhosis ———

Slide 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 forwardlooking 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 materi…

Slide 3

BioVie Overview = —— $670M 20,000 Phase 2; Jf Orphan ’ . Ph3 in 2021 Drug Addressable US US patients Number of FDA- Mid-stage Phase 2 Orphan Drug designations ascites market size; targeted for approved drugs to Orphan drug for ascites and HRS with Projected BIV201 US BIV201 therapy specifically treat candidate; FDA potential 7 years market peak sales of $450 M ascites; Number of Fast Track and will exclusivity**; Patent- with 67% penetration direct competitors seek Breakthrough pending liquid SHifces Nats Therapy status formulations * D'Amico 2014; BioVie poster presentation at AASLD 2019. Assumes three 28-day treatment regimens annually. V |e ©) #* If first to market.

Slide 4

Our initial target is ascites-due to advanced liver cirrhosis - a + Cirrhosis is the 11th leading cause of death in the US’ i . ¥ Our first disease * Resulted in 42,000 US deaths in ° target is ascites, 20171 08 Bl the accumulation a + IN of 6+ liters of fluid scites is the most common 00% \ ihe Ahdoren. major complication? § * For refractory ascites the mean 3 trie one-year survival rate is only 50%? peritoneal cavity (ASCITES) 1CDC National Vital Statistics Report, 2017 Data (BD may Vie

Slide 5

® No effective medlcatlon d'fifions 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 e

Slide 6

Ascites patients incur $5flmn+ in annual treatment costs — 116,000 57,000 iy et e Patients US Hospitalizations of these visits " with require paracentesis readmitted liver cirrhosis Physical withdrawal within and ascites of ascites fluid 30 days Average Average length of stay: Charges: @ Sources: HCUP Nationwide Readmissions Database 2016: Average length of stay and charges for patients requiring paracentesis; BioVie poster presentation at AASLD 2019.

Slide 7

Therapeutic goal: Halt the downward spiral - How ascites develops Blood pooling/ vasodilation Liver is "clogged" by beneath liver cirrhosis causing portal vein pressure (portal hypertension) Decreased effective blood volume ' Activation of neurohormonal systems (RAAS) Sodium and water retention Asates 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 Vie

Slide text above is read directly from the BioVie deck PDF embedded on this page.

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