Annovis Bio, Inc. - ANVS STOCK NEWS

Annovis Bio (NYSE: ANVS) reported Q3 2024 financial results and clinical updates. The FDA granted clearance for pivotal Phase 3 studies of buntanetap in early Alzheimer's disease, with a 6-month symptomatic study starting Q1 2025. The company reported $13.6 million in cash and equivalents, with Q3 operating expenses of $4.4 million. Net loss was $0.97 per share, compared to $1.63 in Q3 2023. The company raised $4.4 million from ELOC facility and $7.1 million from warrant exercises. Three new patents were filed for combination therapies involving buntanetap.

Annovis Bio (NYSE: ANVS) has appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist to oversee medical, ethical, and scientific quality of the company's clinical trials. Peterson joins with experience from Axogen, Ethicon, Exactech, and the Department of Veterans Affairs. His appointment comes as Annovis approaches initiation of pivotal Phase 3 studies. Peterson holds a Ph.D. in Biomedical Engineering from the University of Florida and will contribute to the clinical development of buntanetap for neurodegenerative diseases like Alzheimer's and Parkinson's.

Annovis Bio Inc. (NYSE: ANVS) announced it will present two scientific posters at the 17th Clinical Trials on Alzheimer's Disease (CTAD) conference in Madrid, Spain, from October 29 to November 1, 2024. The presentations will highlight the progress of buntanetap, the company's drug candidate for neurodegenerative disorders like Alzheimer's and Parkinson's disease.

Dr. Maria Maccecchini, President and CEO of Annovis Bio, will present two posters:

• Poster LP023: 'Efficacy of Buntanetap in Early AD and APOE4 Phase 2/3 Alzheimer's Patients'
• Poster LP074: 'Biomarker Data Showed Buntanetap Reduced Neurotoxic Proteins, Improved Axonal Integrity, Reduced Inflammation, and Neuronal Functions in Alzheimer's Clinical Studies'

The posters will be available on Annovis' website after the conference concludes.

Annovis Bio Inc. (NYSE: ANVS) has received FDA clearance to proceed with pivotal Phase 3 studies for its Alzheimer's disease (AD) treatment, buntanetap, following a successful End-of-Phase 2 meeting. The FDA's decision is based on Phase 2/3 clinical data showing symptomatic improvement in early AD patients. The Phase 3 program will include two trials: a 6-month study for symptomatic effects and an 18-month study for potential disease-modifying effects.

The FDA raised no concerns about buntanetap's safety data and confirmed that development can proceed using the new crystal form. Annovis aims to file two New Drug Applications (NDAs), one for short-term and one for long-term efficacy. The company plans to initiate the trials early next year, with the possibility of an NDA filing within one year of the 6-month study's start, pending successful execution.

Annovis Bio Inc. (NYSE: ANVS) is leading the development of safe and effective drugs for neurodegenerative diseases, particularly Alzheimer's Disease (AD). The company's primary focus is improving nerve cell health and cognition in neurodegenerative disorders. Buntanetap, Annovis Bio's lead drug candidate, has shown promising results in late-stage clinical trials for both AD and Parkinson's Disease (PD).

Earlier this year, Annovis announced encouraging outcomes from a phase 2/3 clinical trial of buntanetap as an oral therapy for early AD. The study, which involved 353 patients, evaluated buntanetap's efficacy when used alongside standard care medications and assessed its safety profile. These results highlight Annovis Bio's potential to transform Alzheimer's treatment through innovative drug combinations aimed at boosting cognition.

Annovis Bio Inc. (NYSE: ANVS) has announced promising early research results for its lead drug, buntanetap, in combination with other approved drugs for Alzheimer's disease (AD) treatment. While recent FDA-approved drugs like Leqembi and Kisunla may slow cognitive decline in AD patients, they do not improve cognition. Similarly, GLP-1 drugs, originally developed for type 2 diabetes and obesity, have shown potential in AD treatment but do not enhance cognitive functions.

Annovis Bio's innovative approach aims to address this critical gap in AD treatment. The company's research suggests potential future breakthroughs in improving cognition for AD patients, a significant target for millions suffering from this progressive disease. This development positions Annovis Bio as a notable player in the pharmaceutical industry's efforts to transform Alzheimer's treatment.

Annovis Bio Inc. (NYSE: ANVS) has filed three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, aimed at treating neurodegenerative diseases like Alzheimer's and Parkinson's.

Recent preclinical studies have shown that combining buntanetap with a GLP-1 agonist (like Trulicity) or PDE5 inhibitors (like Viagra) improves cognitive function in Alzheimer's mouse models beyond levels observed in healthy controls. The company's CEO, Maria Maccecchini, Ph.D., stated that early data suggests a strong synergistic effect, potentially restoring and improving cognition beyond normal levels.

As buntanetap has completed Phase 3 studies as a standalone treatment, and both Trulicity and Viagra are FDA-approved, these combinations are well-positioned for Phase 3 human trials. This development expands Annovis's pipeline and advances its mission to enhance cognition for those suffering from neurodegenerative disorders.

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focusing on neurodegenerative diseases, will participate in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. The event will be held both virtually and in-person at the Lotte New York Palace Hotel.

Dr. Maria L. Maccecchini, Founder, President, and CEO of Annovis Bio, will deliver a company presentation on Tuesday, September 10, 2024, from 8:00 - 8:30 a.m. ET. She will also participate in a panel discussion on 'Non-amyloid Approaches in Alzheimer's Disease' on the same day from 2:00 - 3:00 p.m. ET, alongside representatives from Anavex Life Sciences Corp. and Longeveron Inc.

The presentation will cover Annovis' recent advancements and strategic direction, followed by a Q&A session. Attendees can schedule one-on-one meetings with Dr. Maccecchini through the conference portal or by contacting meetings@hcwco.com.

Annovis Bio (NYSE: ANVS) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Completed pivotal Phase 2/3 Alzheimer's and Phase 3 Parkinson's studies with encouraging data for buntanetap.

2. Introduced a new crystalline form of buntanetap with improved properties.

3. Q2 2024 financial results: $4.0 million in cash and cash equivalents as of June 30, 2024; $7.8 million in total operating expenses; $0.44 basic and diluted net loss per share.

4. Received $7.1 million from warrant exercises and $7.0 million from ELOC facility, bringing cash position to $12.1 million as of August 14, 2024.

5. Filed new patents for buntanetap's crystalline form and manufacturing process.

6. Expanded team with key appointments in business development, communications, statistics, and quality.