Annovis Bio Inc Stock Price, News & Analysis

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.

Annovis Bio (NYSE: ANVS) has completed its previously announced public offering, raising $21 million in gross proceeds. The offering consisted of 5,250,000 shares of common stock and warrants to purchase an additional 5,250,000 shares at a combined price of $4.00 per share and associated warrant. The warrants are immediately exercisable at $5.00 per share for five years.

The company plans to use the net proceeds primarily to fund the Phase 3 clinical development of Buntanetap for Alzheimer's disease, along with working capital and general corporate purposes. ThinkEquity served as the sole book-running manager for the offering, which was conducted under a shelf registration statement on Form S-3.

Annovis Bio (NYSE: ANVS) has announced the pricing of a public offering consisting of 5,250,000 shares of common stock and warrants to purchase an equal number of shares at a combined price of $4.00 per share. The warrants will have an exercise price of $5.00 per share, exercisable immediately for five years after issuance.

The offering is expected to raise $21 million in gross proceeds before deducting underwriting discounts and expenses. The company plans to use the net proceeds for working capital and general corporate purposes, including the continued clinical development of their lead compound, Buntanetap. ThinkEquity is serving as the sole book-running manager for the offering, which is expected to close on February 4, 2025.

Annovis Bio (NYSE: ANVS) has announced plans for an underwritten public offering of common stock and warrants. ThinkEquity will serve as the sole book-running manager, with a 45-day option to purchase up to an additional 15% of shares and/or warrants to cover over-allotments.

The company intends to use the proceeds primarily for working capital and general corporate purposes, including the continued clinical development of their lead compound, Buntanetap. The offering will be made through a shelf registration statement on Form S-3 filed with the SEC.

Annovis Bio is a late-stage clinical drug platform company focusing on transformative therapies for neurodegenerative diseases, particularly Alzheimer's and Parkinson's disease. The completion and terms of the offering are subject to market conditions.

Annovis Bio (NYSE: ANVS) has been granted a U.S. patent for using buntanetap in the treatment and prevention of acute brain or nerve injuries. The patent, issued on January 2, 2025, extends the company's global protection, as similar patents have already been granted in the EU, Japan, and other regions worldwide.

The patent is based on buntanetap's capability to reduce neurotoxicity and mitigate neurodegenerative processes, making it potentially applicable to conditions such as stroke, ischemia, traumatic brain injury, micro infarcts, and other acute injuries. This expands the potential applications of buntanetap beyond its primary indications of Alzheimer's and Parkinson's diseases.

Annovis Bio (NYSE: ANVS) announced that the FDA has accepted an updated protocol for its pivotal Phase 3 Alzheimer's Disease (AD) study, set to begin in January 2025. The revised protocol integrates two separate trials into a single 6/18-month trial. The original design included a 6-month symptomatic study and an 18-month disease-modifying study. Now, the consolidated protocol features a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment for disease-modifying potential.

In October 2024, the FDA granted clearance for Annovis to proceed based on Phase 2/3 data showing cognitive improvement in early-stage AD patients. According to Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, this streamlined approach will accelerate the development timeline while maintaining scientific rigor. The 6-month symptomatic data could potentially support a New Drug Application (NDA) filing, continuing seamlessly to evaluate long-term outcomes.

This development marks a significant step in advancing buntanetap as a novel treatment for AD, bringing the company closer to delivering new therapeutic options for patients.

Annovis Bio (NYSE: ANVS) recently showcased its breakthrough drug development for neurodegenerative diseases on Today's Marketplace. CEO Maria Maccecchini and Dr. Scott Shipman discussed the company's promising clinical trials targeting Alzheimer's and Parkinson's diseases.

The company's once-daily pill uniquely targets multiple toxic proteins, including plaques, tangles, and Lewy bodies that kill nerve cells in the brain. Clinical studies have demonstrated not just slowed progression but actual improvement in symptoms - enhanced cognition in early Alzheimer's patients and improved cognition and function in Parkinson's patients.

With over 7 million people affected by neurodegeneration in the United States, the impact extends beyond patients to caregivers and healthcare workers. The company is currently seeking funding for next-phase trials of this potentially groundbreaking treatment.

Annovis Bio (NYSE: ANVS), a clinical-stage drug platform company focused on neurodegenerative diseases, announces an upcoming live investor webcast on December 11, 2024, at 4:30 PM EST. Dr. Maria Maccecchini, Founder, President, and CEO, will present comprehensive updates on the company's achievements and future plans.

The webcast will cover key topics including updates on Phase 3 studies for Parkinson's and Alzheimer's diseases, FDA interactions, financial health, and strategic initiatives for 2025. Participants can submit questions in advance to ir@annovisbio.com for the Q&A session following the presentation.

Annovis Bio announced its President and CEO, Maria Maccecchini, Ph.D., will present at the National Institute on Aging (NIA) workshop on Dementia with Lewy Bodies. The workshop, titled 'Dementia with Lewy Bodies: Filling the Gaps in Translational and Clinical Research,' is jointly sponsored by NIA and the National Institute of Neurological Disorders and Stroke (NINDS). The event will take place on November 12-13, 2024, and will be available online for registered attendees.

Dr. Maccecchini's presentation, 'One Drug, Dual Effect: Buntanetap Improves Cognitive and Motor Functions, Benefiting Alzheimer's and Parkinson's Patients. A Potential Path for Lewy Body Dementia?' is scheduled for November 13 at 2:20-2:35 PM ET.