Annovis Bio, Inc. - ANVS STOCK NEWS

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.

Annovis Bio Inc. (NYSE: ANVS) has announced new preclinical data showing a synergistic effect between its lead compound, buntanetap, and the GLP-1 agonist dulaglutide in an Alzheimer's disease mouse model. The combination not only restored cognitive function but also enhanced it beyond healthy control levels. This follows recent data presented at AAIC 2024, where another GLP-1 agonist, liraglutide, showed promise in reducing cognitive decline and brain shrinkage in Alzheimer's patients.

Buntanetap alone restored cognitive function to 100%, while dulaglutide alone achieved 80%. The combination resulted in a 6- to 10-fold increase in efficacy. Annovis CEO Maria Maccecchini highlighted the potential of this approach in developing more effective treatment options for Alzheimer's patients as research shifts towards combination therapies.

Annovis Bio (NYSE: ANVS) has secured a U.S. patent for treating acute traumatic brain injuries (TBI) with its lead drug candidate, buntanetap. The patent (No. 12,042,482) covers methods for treating TBI and preventing nerve cell death. This achievement strengthens Annovis Bio's portfolio, which includes patents for using buntanetap in acute and chronic neurodegenerative diseases and mental illnesses.

CEO Maria Maccecchini highlighted the significance of this milestone, emphasizing buntanetap's potential to address nerve cell death in various brain conditions. Preclinical studies in TBI and stroke animal models have shown buntanetap's efficacy in preventing cell death and loss of function, demonstrating its potential benefits for brain trauma victims.

Annovis Bio (NYSE: ANVS) has received FDA approval to transition to a new crystal form of buntanetap in future clinical trials. This follows the company's June 2024 announcement of filing a composition of matter patent for the new crystal form and a provisional patent for its manufacturing process. Annovis conducted comprehensive bridge studies comparing the old semi-crystalline form with the new crystalline form in various solvents and animals. The company also developed a large-scale manufacturing process for the new form. The FDA's approval allows Annovis to conduct a comparative bioavailability study in humans as part of the transition process.

Annovis Bio (NYSE: ANVS) has announced the addition of four new executives to its leadership team, aiming to enhance their efforts in developing treatments for neurodegenerative disorders like Alzheimer's and Parkinson's diseases.

Mark White, a global pharmaceutical marketing expert who served as VP of Worldwide Marketing at Pfizer, is now the Chief Business Officer. Dr. Alexander Morin, with a background in neuroscience and strategic communications, has been appointed Director of Strategic Communications. Hilda Maibach, an expert in clinical and observational studies with over 30 years of experience, is the new Senior Vice President of Statistics. Lastly, Blake Jensen, with two decades of experience in quality management and regulatory inspections, has been appointed Head of Quality.

CEO Dr. Maria Maccecchini emphasized that these leadership additions are important as Annovis Bio advances its drug candidate buntanetap towards regulatory approval and market introduction.

Annovis Bio released promising new data from its Phase III study on buntanetap for Parkinson’s Disease (PD). The drug showed dose-dependent, statistically significant improvements in cognition and motor functions. Key findings include significant enhancements in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores and cognitive function, particularly in patients with over three years of PD diagnosis and those with Postural Instability and Gait Difficulties (PIGD). Buntanetap also halted cognitive decline in all patients and improved cognition in those with mild dementia. The safety profile was consistent across all groups. The company is committed to advancing buntanetap to further explore its benefits.

Annovis Bio announced the filing of a provisional patent for a new manufacturing process of a crystalline form of buntanetap, a drug for neurodegenerative disorders like Alzheimer's and Parkinson's diseases. This new process provides significant benefits, including high product purity, excellent yields, and the avoidance of genotoxic reagents. The company aims to submit the Chemistry, Manufacturing, and Controls (CMC) protocol to the FDA in July, with plans to continue the drug's development and file a New Drug Application (NDA).

Annovis Bio announced filing a new composition of matter patent with the U.S. Patent and Trademark Office for novel crystalline forms of buntanetap, enhancing its solubility and stability for treating neurodegenerative disorders like Alzheimer’s and Parkinson’s. This builds upon a provisional patent from June 2023. The most stable crystal form has been selected for animal bridge studies and manufacturing process development. These studies were submitted to the FDA and will be discussed in July. This patent provides 20-year protection, aiding the company's drug development and market introduction plans.

Annovis Bio (NYSE: ANVS) has scheduled a webcast for July 2, 2024, at 4:30 PM ET to discuss developments concerning its lead drug candidate, Buntanetap, which targets neurodegenerative disorders like Alzheimer's and Parkinson's diseases. The webcast will cover recent advancements, strategic plans for upcoming clinical trials, and an overview of the company's progress and future direction. Investors and interested parties are encouraged to register in advance for the event.