• Annovis provided business and financial updates for Q3 2024, spotlighting progress toward pivotal buntanetap trials in Alzheimer’s disease.
• The FDA has cleared Annovis to proceed with a Phase 3 program, which will include a 6-month study to confirm buntanetap’s symptomatic benefits (beginning Q1 2025) and an 18-month study to explore potential disease-modifying effects.
• Matthew Peterson, Ph.D., was appointed as Senior Clinical Scientist and will oversee quality and rigor in upcoming clinical trials.
• Annovis filed three new patents for innovative combination therapies, involving buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), and a combination of all three.
• As of Nov. 8, 2024, the company reported a cash position of $13.6 million, providing sufficient runway to support all Phase 3 preparatory activities and to initiate the pivotal Phase 3 Alzheimer’s study in Q1 2025.

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), concluded the third quarter with significant milestones achieved and a clear path forward for its lead candidate, buntanetap.

Buntanetap is an innovative drug designed to target neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. This multifaceted inhibition improves synaptic transmission and axonal transport, reduces neuroinflammation, and protects nerve cells from dying, positioning buntanetap as a potential breakthrough in treating neurodegenerative diseases.

The drug candidate has been shown effective in improving the health of nerve cells and therefore cognition in AD and cognition and motor function in PD patients. Annovis recently completed a Phase 2/3 AD study, with encouraging results that were presented to the U.S. Food and Drug Administration (“FDA”) on Oct. 10, 2024. During that meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies: a 6-month study aimed at confirming buntanetap’s symptomatic effects, set to begin in Q1 2025, and an 18-month study designed to demonstrate potential disease-modifying effects. The FDA also recognized buntanetap’s safety, raising no concerns regarding liver enzyme levels, drug interactions, dose selection, pharmacokinetics, population pharmacokinetics and confirmed that development could proceed using the new crystal form of buntanetap.

To ensure the successful completion of upcoming clinical trials, the company appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist, who will be responsible for quality and rigor in the next studies.

“The third quarter was a milestone period that has clearly defined our path forward for buntanetap,” said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. “With FDA approval to launch confirmatory Phase 3 studies in early AD, our team is focused on initiating a 6-month pivotal trial early next year. We also bolstered our IP portfolio with new patents for combination therapies involving buntanetap, reinforcing our commitment to finding innovative solutions for these debilitating conditions.”

The three new patents, filed on Sept. 30, 2024, cover combination therapies involving buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, creating a multifaceted approach to treating neurodegenerative diseases.

During the third quarter, Annovis presented two posters at the 17th Clinical Trials on Alzheimer’s Disease (“CTAD”) conference in Madrid, showcasing buntanetap’s efficacy in Phase 2/3 AD study and the biomarker data.

In terms of Q3 financial results, the company announced that it has an adequate runway for all Phase 3 preparatory studies and for entering the pivotal Phase 3 AD study in Q1 2025, having cash and cash equivalents of $13.6 million as of Nov. 8, 2024.

For more information about the company, visit www.AnnovisBio.com, and social channels LinkedIn, X and YouTube.

NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://ibn.fm/ANVS

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