BioVie issues letter to shareholders

BioVie issued the following letter to shareholders: "Dear shareholders, The company has made significant progress with our clinical programs and released additional data within the last week… The key points to takeaway are: Parkinson’s disease patients treated with NE3107 for 28 days experienced a clinically meaningful increase in motor control. Additional data presented at the Clinical Trials in Alzheimer’s Disease conference showed that NE3107 enhanced cognition as measured by a variety of assessment tools… NE3107 appears to impact biomarkers of aging-related disease states and reduces Horvath DNA methylation SkinBlood clock by 3.3 years after 3 months of treatment… The NM201 study is a… study in Parkinson’s disease. This trial was launched with two design objectives: 1) the primary objectives are to demonstrate safety and the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective is to determine if NE3107’s promotoric activity observed in nonhuman primates can be seen in humans. The trial met both objectives… This trial is primarily a safety and drug-drug interaction study that we expanded in hopes of finding an efficacy signal. The fact that this small trial showed this magnitude of therapeutic impact for NE3107 allows us to proceed with planning the Phase 3 program for discussion with the FDA. NE3107 enhances cognition The company supported an Investigator-Sponsored 2 trial to explore NE3107’s impact on biomarkers and brain imaging in mild cognitive impaired and mild AD patients… These data showed the following among patients with MMSEgreater than=20: Patients demonstrated enhanced thinking, memory, and function after three months of treatment with NE3107 compared to baseline as measured using multiple rating scales… Improvements in inflammation correlated with improvements in cognition. Patients experienced a reduction of CSF phospho-tau levels of -1.66 pg/mL and the ratio of p-tau to Ab42 by -0.0024 … 18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions as seen from advanced functional MRI studies. MCI and mild AD subjects with abnormal scans that improved after 3 months treatment also saw a -0.068 points improvement in their ADCOMS scores… We also recently announced that BioVie’s Phase 3 trial in AD has fully enrolled the targeted 316 patients and that the company is opting to increase study size to 400 due to our fast enrollment pace… We believe all 400 patients can be enrolled in the coming months and anticipate topline results will be available before the end of 3Q2023. By taking this step we believe we have enhanced our probability for success, and thus our ability to bring this hoped for innovation to the Alzheimer’s patient community… As a part of the Phase 2 Alzheimer’s trial, blood samples were taken from the patients before and after 3 months of treatment with NE3107, and these samples were analyzed to assess NE3107’s potential to reduce inflammation and alter DNA methylation patterns associated with epigenetic biological clocks. Data shows that treatment with NE3107 for three months showed a reduction of 3.3 years using the Horvath DNA methylation SkinBlood clock. Furthermore, 19 out of the 22 patients experienced this reduction in the SkinBlood clock score…Overall, we are very excited with the progress of our clinical programs and the potential of advancing meaningful therapies for our patient communities…Given the efficacy signal detected in the Parkinson’s Phase 2 trial, we will start planning the next phase of the clinical development program for discussion with the FDA in anticipation of launching the Phase 3 for PD trials in 2023 as well."