BioVie (BIVI) Corporate presentation summary

Platform and pipeline

• Clinical-stage pipeline targets neurodegeneration, Long COVID and liver disease; bezisterim is an oral TNFα inhibitor, while BIV201 is continuous-IV terlipressin for ascites.

• Bezisterim’s proposed mechanism blocks ERK/NFκB-mediated inflammatory signaling; it is described as orally bioavailable, blood-brain-barrier penetrating, with no significant safety issues identified through Phase 3 testing.

• Indications span Parkinson’s disease, Long COVID and Alzheimer’s disease for bezisterim, plus ascites for BIV201; stated annual US sales potentials are $3B, $10B, $30B and $1.6B, respectively.

• Near-term milestones include Parkinson’s Phase 2b topline data in August 2026, Long COVID Phase 2 topline data in September 2026, and further clinical updates and FDA feedback on Parkinson’s Phase 3 design in 2H 2026.

Parkinson’s disease

• In the SUNRISE-PD ITT population (N=57), bezisterim showed smaller mean worsening than placebo on UPDRS Parts I, II and total; EPNIC-15 change was -0.04 vs +0.18 (Cohen’s d -0.94; p=0.0006).

• Among participants with baseline platelets >230 (n=27), EPNIC-15 favored bezisterim (Cohen’s d -1.61; p=0.0002); UPDRS Parts I, II, III and total also favored treatment, with p-values from 0.0062 to 0.0418.

• Proteomic analysis found 283/380 proteins (74.5%) shifted in a direction associated with slower progression; neuronal-injury biomarkers showed a composite treatment effect versus placebo (Cohen’s d -0.62; p=0.025).

• In the Phase 2b safety population, any adverse events occurred in 57.1% with bezisterim and 58.6% with placebo; there were no serious or severe events or deaths, and one treatment-related AE in each arm.

• Proposed Phase 3: 160 levodopa-naïve early-PD patients, primary endpoint UPDRS total at 6 months, with 100 participants above and 60 at or below the 230 platelet threshold; a 6-month open-label extension is planned.

Long COVID

• ADDRESS-LC was designed as a signal-finding and proof-of-concept Phase 2 trial, assessing 22 clinical outcomes and blood biomarkers, including a 380-protein proteomics panel; it received a fully funded DoW award through PRMRP.

• The ITT trial population was 203; bezisterim was reported to show an advantage on virtually all assessed endpoints, though listed p-values ranged from 0.0760 to 0.9480.

• Greater baseline fatigue was associated with larger PROMIS Fatigue improvements across quartiles; the treatment comparison had p=0.0178.

• High-symptom subgroups showed statistically significant results across selected fatigue, cognition and post-exertional malaise measures, including p=0.0040 for verbal learning in the high-fatigue subgroup and p=0.0116 for global cognition in the high cognitive-impairment subgroup.

• Any treatment-emergent adverse event occurred in 41.6% with bezisterim versus 55.9% with placebo; there were no deaths, and serious events occurred in 0 vs 1 participant, respectively.