BioVie issues letter to shareholders

BioVie issued the following letter to shareholders: “The company has made tremendous progress since I last wrote you in December… What we know from completed clinical trials. Let me start by reviewing the Phase 2 exploratory biomarker study we completed in 2022… MCI and mild AD patients treated with NE3107 experienced enhanced cognition as measured by multiple assessment tools, including a 2.1 points improvement on the ADAS-Cog11 scale… NE3107 reduced CSF phospho-tau levels by -1.66 pg/mL and the ratio of p-tau to amyloid beta 42 by -0.0024…18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions as seen from advanced MRI techniques.. Patients saw significant reductions in the methylation of their DNA, which was equivalent to -3.3 years on the Horvath DNA methylation Skin Blood Clock… No drug-related adverse events were observed… Taken it its totality, we believe the data suggest that NE3107 may have the potential to reduce epigenetic changes driven by inflammation and that NE3107 may have the potential to reduce inflammation and oxidative stress, restore homeostatic regulation and enable the recovery of gene expression… Our NM101 trial has been fully enrolled since February 2023 and is nearing its completion by the end of September. Topline data readout is expected in the October-November timeframe. As we approach data readout, I am increasingly optimistic about what we hope to see based on the totality of the data that we have disclosed… Additionally, the data we recently presented at the 83rd Scientific Sessions of the American Diabetes Association that took place June 23-26 give further support for what we can expect… The large majority of patients had elevated inflammatory markers and were overweight… Patients who are amyloid beta positive had comparable CDR-SB scores at baseline as those who are Abeta negative… Abeta+ patients had worse ADAS-Cog12 and MMSE scores than the Abeta- patients, while the Abeta- patients had significantly higher inflammation, insulin resistance, IFG, and hypertension, compared to their Abeta+ counterparts… In the end, we believe cognitive decline or improvement starts with neuronal health…. Based on our understanding of how NE3107 potentially works and the data that have been revealed, we believe that NE3107 may have a broad and multisystem regulatory effect… Based on all of this, we believe we have a sound scientific and epigenetic explanation of why NE3107 may work, and we now await the NM101 trial readout to confirm all this.”