Annovis Bio (NYSE:ANVS) FY Conference Transcript

Summary of Innovus Bio Conference Call Company Overview - Company: Innovus Bio - Drug: Buntanetab - Indication: Alzheimer's Disease - Current Phase: Phase three pivotal study Key Points and Arguments Alzheimer's Drug Development Landscape - Historical context: Several drugs developed around 2000 improved cognition short-term, followed by a 20-year period with no approvals [2][3] - Recent approvals focus on slowing cognitive decline rather than improving cognition [3] - Over 180 ongoing Alzheimer's studies indicate a surge in drug development [3] Buntanetab's Unique Mechanism - Buntanetab is positioned as a disease-modifying drug that improves cognition short-term while protecting nerve cells long-term [4][7] - It is orally available, easy to administer, and has no side effects [8] - Targets four toxic proteins associated with Alzheimer's: plaque, tau, alpha-synuclein, and TDP-43 [11][12] - Acts on mRNA to inhibit the synthesis of these proteins, differentiating it from existing drugs [12] Efficacy in Animal Studies - Demonstrated both symptomatic and disease-modifying efficacy in eight different animal models [23] - Protects nerve cells from dying in traumatic brain injury and glaucoma models [21][22] Human Clinical Trials - Conducted 12 studies in humans, including small studies in healthy volunteers and early Alzheimer patients [23] - Small studies showed significant improvement in cognition compared to placebo, with a 3.5 to 4.5 ADS cog points improvement [25] - A larger study with 350 patients did not meet primary endpoints but showed a significant dose-response curve in early moderate patients [26][27] - Ongoing large study with 760 early Alzheimer patients lasting 18 months, with dual endpoints for symptomatic and disease modification [36] Comparison with Existing Treatments - Buntanetab shows a 3 to 4 point improvement in ADS cog at three months, compared to existing drugs like Aricept and Kisumbla, which show limited efficacy over time [31][34] - The drug works effectively across various demographics, including APOE4 positive and negative patients [27][28] Future Outlook - Anticipated NDA filings: Six-month data by the end of next year and 18-month data by 2027 [36] - The study design includes both symptomatic and disease-modifying endpoints, with a focus on volumetric MRI and biomarkers [37] Intellectual Property - Innovus Bio has 13 patent families extending patent life until 2044, including a novel crystal form developed last year [38] Additional Important Information - The drug's mechanism improves axonal transport, which is crucial for cognitive function [15][20] - Inflammation reduction is achieved indirectly by keeping nerve cells healthy, thus preventing immune system attacks [19][20] - The drug's efficacy is supported by biomarker improvements in neurofilament light and inflammatory factors [30]