BioVie (BIVI) investor relations material

Clinical trial progress and timelines

• Phase II Parkinson's trial enrollment has accelerated, with full enrollment expected by end of 2024 and data readout projected for April or May 2026.

• Long COVID Phase II trial is enrolling well, with further guidance on full enrollment expected within a month and data readout anticipated in mid-2025.

• Ascites Phase III protocol was submitted to the FDA three weeks ago, with feedback expected within thirty days, enabling a potential start pending funding.

• Sufficient cash runway extends into 2026, covering the period for key trial readouts.

Drug candidates and mechanisms

• Lead asset bezesterone targets TNF alpha, reducing inflammation and insulin resistance, with positive effects in Parkinson's and Alzheimer's patients.

• Bezesterone blocks activation of ERK and NF kappa B, avoiding toxicity seen in prior ERK inhibitors.

• Preclinical and clinical data show bezesterone improves muscle control and may have neuroprotective properties in Parkinson's.

• BIV201, for ascites, demonstrated a 50% reduction in fluid volume in Phase IIb, leading to early trial termination for efficacy.

Market potential and financial outlook

• Bezesterone for Parkinson's is estimated to have $3–5 billion annual sales potential in the US with 10% market penetration.

• BIV201 for ascites could reach $1.6–2 billion in annual US sales.

• Current market cap is $15 million, with significant upside if trials succeed.

• $25 million is being sought to fund the ascites Phase III trial.