Annovis Bio Inc Stock Price, News & Analysis

Annovis Bio (NYSE: ANVS) reported its Q1 2025 financial results and provided corporate updates. The company has initiated a pivotal Phase 3 clinical trial for buntanetap in early Alzheimer's disease, which began enrolling patients on February 5, 2025. The trial aims to treat 760 participants and will evaluate both symptomatic benefits (6 months) and disease-modifying effects (18 months). Financial highlights include cash and cash equivalents of $22.2 million (up from $10.6M YoY), R&D expenses of $5.0M (down from $6.5M YoY), and G&A expenses steady at $1.3M. The company reported a net loss of $0.32 per share. Notable achievements include securing a U.S. patent for buntanetap in treating acute brain and nerve injuries, and presenting research findings at multiple scientific conferences.

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on neurodegenerative disorders, has appointed Hui Liu as Director of Biostatistics. This strategic hire comes as the company advances its pivotal Phase 3 Alzheimer's disease trial.

Ms. Liu brings over 19 years of experience in clinical trial statistics, specializing in:

• Design and analysis of all clinical trial phases
• Statistical methodology expertise
• Development of statistical analysis plans
• Management of high-performing teams

According to Dr. Cheng Fang, Senior VP of Research and Development, Liu's appointment strengthens the company's scientific excellence and will support data integrity for regulatory submissions. The new Director expressed enthusiasm about joining Annovis's team and contributing to their clinical trials' quality evidence generation.

Annovis Bio (NYSE: ANVS) has received a notice from the NYSE on March 26, 2025, indicating non-compliance with continued listing standards. The company's average global market capitalization over 30 trading days fell below $50 million (approximately $37.9 million as of March 25, 2025), while stockholders' equity was $9.3 million as of December 31, 2024.

The company must submit a compliance plan within 45 days, demonstrating its ability to meet NYSE standards within 18 months. During this period, ANVS stock will continue trading with a '.BC' designation. If the plan is accepted, quarterly reviews will ensure compliance. Failure to meet requirements could result in NYSE delisting.

Annovis Bio (NYSE: ANVS) announced its participation in the AD/PD™ 2025 conference taking place April 1-5 in Vienna, where they will present comprehensive data from their latest clinical trials.

The company will deliver two key presentations: one focusing on buntanetap's improvements in cognition and motor functions in Phase 3 Parkinson's disease study, and another examining the drug's advantages for APOE4 carriers in Phase 2/3 Alzheimer's disease trials. Additionally, CEO Maria Maccecchini will participate in a forum discussion about novel approaches to biomarkers, imaging, and therapy development.

The presentations schedule includes:

• April 1, 2:45 PM CET: Buntanetap's impact on early Parkinson's patients
• April 2, 9:40 AM CET: APOE4 and buntanetap in Alzheimer's patients
• April 4, 4:20 PM CET: Forum on novel approaches in PD, LBD and MSA pathologies

Annovis Bio (NYSE: ANVS) reported its Q4 and FY 2024 financial results, highlighting significant clinical progress in their buntanetap program. The company successfully completed two clinical trials - Phase 2/3 Alzheimer's Disease (AD) and Phase 3 Parkinson's Disease (PD), with promising results in improving cognition and motor function.

Financial highlights include:

• Q4 2024 R&D expenses decreased to $5.0M from $8.9M in Q4 2023
• Q4 2024 net loss per share improved to $0.43 from $2.24 year-over-year
• FY 2024 R&D expenses reduced to $20.0M from $38.8M in 2023
• Cash position of $10.6M as of December 31, 2024
• Completed $21.0M stock offering with ThinkEquity

The FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, launched in early 2025. The study includes a 6-month symptomatic data readout expected in mid-2026 and disease-modifying data in mid-2027, both supporting potential New Drug Applications.

Annovis Bio (NYSE: ANVS) announced its participation in the 13th Alzheimer's & Parkinson's Drug Development Summit in Boston, MA, from March 18-20, 2025. The company's Founder and CEO, Maria Maccecchini, Ph.D., will present Phase III buntanetap data and participate in a panel discussion on March 19.

The presentation at 3:30pm EST will focus on buntanetap's clinical trial results and advocate for a holistic approach to treating neurodegenerative diseases. At 4:30pm EST, Dr. Maccecchini will join a panel exploring opportunities in alpha-synuclein and future developments in Parkinson's drug development.

The company emphasizes the need to move beyond single-protein targeting approaches, highlighting their strategy of addressing multiple neurotoxic proteins in treating conditions like Alzheimer's and Parkinson's disease.

Annovis Bio (NYSE: ANVS), a clinical-stage drug platform company focused on neurodegenerative diseases, announces a live webcast Patients' Forum scheduled for February 27, 2025, at 4:30 PM EST. CEO Maria Maccecchini, Ph.D., will lead the session, addressing questions from patients, caregivers, and families.

The forum will provide updates on several key areas including:

• Ongoing Phase 3 Alzheimer's disease trial
• Plans for Phase 3 Parkinson's disease study
• Open Label Extension studies
• Patient communication strategies

The event will feature a presentation of recent achievements followed by a Q&A session. Participants can submit questions in advance to clinicaltrials@annovisbio.com. While open to all, the forum is specifically designed for patients, families, and caregivers, demonstrating Annovis's commitment to transparency and patient-centered communication.

Annovis Bio (NYSE: ANVS) has announced its participation in Oppenheimer's 35th Annual Healthcare Life Sciences Conference. CEO Maria Maccecchini, Ph.D., will deliver a presentation on February 11, 2025, from 12:40 to 1:10 p.m. ET through the conference's virtual platform.

The presentation will focus on the company's recent developments, particularly highlighting progress in their pivotal Phase 3 trial for early Alzheimer's disease. Dr. Maccecchini will also discuss strategic initiatives regarding a New Drug Application (NDA) for buntanetap, which is being developed as both a symptomatic and potentially disease-modifying treatment.

The conference is a significant industry event that connects leading healthcare and life sciences companies with investors, offering a platform for executives to share insights on industry trends, innovations, and investment opportunities.

Annovis Bio (NYSE: ANVS) has initiated its pivotal Phase 3 study of buntanetap for early Alzheimer's disease (AD) with the enrollment of the first two patients. The randomized, placebo-controlled, double-blind study will evaluate the drug's safety and efficacy over 18 months, divided into a 6-month assessment of symptomatic effects and a 12-month evaluation of disease-modifying effects.

The study follows positive Phase 2/3 trial results showing significant cognitive improvement in early AD patients with no safety concerns. The company recently raised $21 million through a public offering to fund the initial 6-month portion, with the remaining 12-month phase expected to be funded through warrant exercises.

The trial will enroll over 750 participants across approximately 100 U.S. sites, with primary outcomes measured using the ADAS-Cog13 subscale for cognition and ADCS-iADL scale for functional ability. The first two sites have begun recruiting in Winter Park, FL and Tom's River, NJ.