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Annovis announces partnership with Weave Bio, AI regulatory platform, in preparation of NDA for buntanetap in Alzheimer's disease. MALVERN, Pa., Sept. 23, 2026 (GLOBE NEWSWIRE) - Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced a collaboration with Weave Bio, an AI platform for regulatory content and knowledge management, in support of the planned New Drug Application (NDA) for buntanetap. Under the collaboration, Annovis will use Weave for drafting, reviewing and managing the NDA documents as the Company heads toward a 6-month top-line data readout from the pivotal Phase 3 AD trial - the data that will form the basis of the submission. Annovis' regulatory and clinical teams will retain full responsibility for content, verification and final approval of every document submitted to the U.S. Food and Drug Administration (FDA). "Our goal is to have most of the NDA ready before the data readout, so the path from the top-line results to filing is as short as possible," said Eve Damiano, Senior VP, Regulatory Operations at Annovis. "Weave will let our regulatory team spend time on scientific judgment and strategy while providing essential assistance on assembling documents in a faster and more organized way. That is a meaningful advantage as we prepare a submission for an investigational therapy we believe has the potential to help millions of patients still waiting for a treatment that can change their lives." The collaboration follows the completion of enrollment in Annovis' pivotal Phase 3 AD study (NCT06709014), which enrolled 862 biomarker-confirmed patients, exceeding the original target of 760. The Company aims to reach the database lock for the 6-month treatment period in December 2026, followed by the top-line symptomatic data announcement in March 2027. "Annovis is exactly the kind of company our platform was built for - a team with deep scientific expertise, ambitious timelines, and a vision for the future of AI-driven drug development," said Brandon Rice, CEO and co-founder of Weave Bio. "NDA submissions are not just about writing documents, they are about weaving years of scientific knowledge into a coherent, traceable narrative. We are privileged to help Annovis do that for a disease area that still has no effective treatment." Annovis and Weave Bio have aligned their approach around the FDA's guidance on the use of AI to support regulatory decision-making, issued in January 2025, keeping regulatory professionals in control of AI-assisted drafting, extraction, traceability and review. About Annovis Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor Alerts Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. Forward-Looking Statements This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company's SEC filings under "Risk Factors" in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law. Contact Information: Annovis Bio Inc. 101 Lindenwood Drive Suite 225 Malvern, PA 19355 www.annovisbio.com Investor Contact: Alexander Morin, Ph.D. Director, Strategic Communications Annovis Bio [email protected]

Takeda and Weave Bio collaborate on AI-driven automation in drug development. The joint effort began with AI-assisted IND submission preparation and has since expanded to HAQ and RTQ processes. Takeda has entered a collaboration to introduce Weave Bio's AI-native regulatory automation platform across 14 ongoing drug development programmes in various global markets. The partnership aims to integrate Weave Bio's AI tools with Takeda's regulatory experience to streamline workflows within the regulatory process. The joint effort began with the use of AI to assist investigational new drug (IND) submission preparation and has since expanded to cover health authority question (HAQ) and response to question (RTQ) processes. A research paper co-authored by scientists from Takeda and Weave Bio that documented the IND phase data revealed a 97% reduction in the time required to draft an initial submission in the evaluated use case, from roughly 100 hours to three. The deployment of HAQ and RTQ processes has recorded more than 100 questions without any extraction errors in the assessed dataset and achieved an average AI answer quality score of 68%, surpassing the goal of 50%-70%. Takeda chief regulatory officer and global regulatory affairs head Nahid Latif said: "Takeda is working to become a leader in the responsible application of AI across every area of R&D, helping its teams work more effectively and accelerate the delivery of innovative medicines to patients. "Our collaboration with Weave is an important example of this ambition in action, enabling us to implement AI-driven regulatory workflows while ensuring that regulatory professionals retain responsibility for content, verification and final decision-making." This collaboration comes as global regulatory agencies clarify their stances on the use of AI in drug development, focusing on areas such as safety, validation, and human oversight. In January 2025, the US Food and Drug Administration (FDA) published draft guidance on using AI in regulatory decision-making, with joint guiding principles from the FDA and European Medicines Agency issued in January 2026. Both Takeda and Weave Bio state that their approach supports these regulatory expectations. Last month, Takeda received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults. Give your business an edge with its leading industry insights.