BioVie (BIVI) Status update summary

Clinical trial updates and results

• Bezisterim showed statistically significant improvements in fatigue, malaise, and brain fog for Long COVID patients with those symptoms at baseline, marking the first trial to demonstrate efficacy across all three neural symptoms in this population.

• In the SUNRISE-PD Parkinson's phase II trial, bezisterim slowed disease progression and improved both motor and non-motor symptoms, with statistical significance in patients with high inflammation.

• Biomarker analysis revealed significant reductions in neurodegeneration markers (NfL, GFAP) and beneficial shifts in inflammation and neuronal injury biomarkers with bezisterim treatment.

• Bezisterim maintained a strong safety profile, with no serious adverse events or drug-drug interactions observed in trials.

• Additional biomarker data from the Long COVID trial is expected before year-end, with plans to present at scientific conferences.

Regulatory and development plans

• End-of-phase II meetings with the FDA for both Parkinson's and Long COVID are planned, with formal feedback on phase III designs expected by year-end.

• For Parkinson's, two global phase III trials (160 patients each) are planned to support registration, with one in the U.S. and one ex-U.S.

• For Long COVID, a breakthrough therapy application is being prepared, and only one additional phase III trial may be needed due to the robust phase II data.

• The BIV201 liver drug program is on hold pending improved market conditions and funding for a phase III trial.

• Alzheimer's trials are deprioritized due to funding constraints, with focus on Long COVID and Parkinson's for now.

Financial and strategic updates

• Management has avoided dilutive equity raises at current share prices, using the ATM facility only opportunistically.

• A future capital raise is anticipated after FDA feedback, which is expected to act as a catalyst for share price recovery.

• Short selling and market dynamics have led to significant share price volatility, despite positive clinical results.

• Management, including the CEO, has been buying shares, reflecting confidence in the company's prospects.

• Partnering discussions with large pharma are being reinitiated, with a focus on creating competitive interest post-data release.