Core Viewpoint - Annovis Bio, Inc. is set to launch an Open-Label Extension (OLE) study in January 2026 to assess the long-term safety and efficacy of its drug, buntanetap, in patients with Parkinson's disease [2][3] Study Overview - The OLE study aims to enroll 500 patients over a 36-month treatment period, with participants receiving a once-daily dose of 30mg oral buntanetap [9] - The study will include two cohorts: former participants of previous clinical trials and patients who have been receiving deep brain stimulation (DBS) for at least 12 months [9][10] Objectives and Methodology - The study will evaluate treatment persistence by examining how patient outcomes evolve after discontinuing treatment, providing insights into the long-term effects of buntanetap [5][6] - It will also assess patient responses when treatment is reintroduced, offering a comprehensive view of the drug's effects and durability [6] Addressing Underserved Populations - The inclusion of patients receiving DBS aims to address a gap in clinical research, as this population is often excluded due to complications in outcome assessments [8][10] - The study seeks to evaluate the interaction between buntanetap and DBS, potentially providing additional therapeutic benefits [7][10] Regulatory Advancement - The OLE study is a critical step toward a future New Drug Application (NDA) submission, helping the company meet FDA patient exposure requirements [11] - The study aims to ensure a total of approximately 1,500 treated patients, with specific targets for treatment duration and dosage [11]

Core Viewpoint - Annovis Bio, Inc. is hosting a corporate update webinar to discuss recent progress, ongoing clinical programs, and strategic directions in the development of therapies for neurodegenerative diseases like Alzheimer's and Parkinson's disease [1][2][3] Group 1: Webinar Details - The webinar will be presented by Maria Maccecchini, Ph.D., President and CEO, who will provide a comprehensive update on the company's journey and future plans [2][3] - The event is scheduled for January 28, 2026, at 4:30 p.m. ET, and is open to shareholders, patients, investigators, and other interested parties [7] - Participants are encouraged to submit questions in advance via email [3] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on developing innovative therapies aimed at improving patient outcomes in neurodegenerative diseases [4] - The company is committed to addressing conditions such as Alzheimer's disease (AD) and Parkinson's disease (PD) [4]

Core Insights - Annovis Bio, Inc. is set to present at the 2025 Annual Meeting of the Parkinson Study Group, showcasing its advancements in therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][5] Group 1: Presentation Highlights - The presentation will build on recent Phase 3 PD biomarker data, indicating that patients with amyloid co-pathology show significant cognitive decline, which is counteracted and reversed by the drug buntanetap [2] - A cross-study comparison of completed trials will be introduced, providing a comprehensive overview of cognitive outcomes across all tested indications, particularly highlighting the benefits for patients with amyloid pathology [3] - Findings suggest that individuals with biomarker-confirmed amyloid presence experience the greatest cognitive gains following treatment with buntanetap, validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins [3] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on developing innovative therapies aimed at improving outcomes and quality of life for patients suffering from neurodegenerative diseases [6] - The company is committed to advancing research and showcasing best practices in the field of Parkinson's disease [5]

Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing therapies for neurodegenerative diseases, specifically Alzheimer's disease (AD) and Parkinson's disease (PD) [1][5] Group 1: Conference Presentations - Annovis will present at the 18 Clinical Trials on Alzheimer's Disease (CTAD) conference from December 1-4, 2025, in San Diego, California [1] - The presentations will emphasize progress in Alzheimer's and Parkinson's programs, particularly recent biomarker data that supports the potential disease-modifying activity of the drug buntanetap [2] Group 2: Key Findings and Statements - Maria Maccecchini, Ph.D., President and CEO of Annovis, expressed optimism about sharing findings on biomarkers and cognition, indicating that the data suggests buntanetap could address the root causes of cognitive decline [4] - The biomarker data reinforces the efficacy of buntanetap observed in earlier studies and provides a clearer path for developing effective treatments for patients in need [4] Group 3: Presentation Details - Presentation 1 will focus on "Amyloid co-pathology and cognitive decline in buntanetap-treated Parkinson's disease dementia patients," presented by Cheng Fang, Ph.D., Senior VP, Research & Development [8] - Presentation 2 will cover a "Double 6/18-month Phase 3 study to reproduce symptomatic and potentially show disease-modifying efficacy of buntanetap in treating Alzheimer's disease," presented by Maria Maccecchini, Ph.D., President and CEO [8]

MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its ongoing Pha ...

Core Insights - Annovis Bio Inc. (NYSE:ANVS) is experiencing a significant increase in stock price, trading up 55.91% at $3.65, with a session volume of 12.29 million compared to an average volume of 615.12 thousand [1][4] Group 1: Clinical Data and Efficacy - The company’s late-stage clinical drug platform focuses on neurodegenerative diseases, particularly Alzheimer's and Parkinson's disease, and has revealed new data on the impact of amyloid co-pathology on cognitive outcomes in Parkinson's patients [1] - In a Phase 3 study involving early Parkinson's disease patients, the drug buntanetap halted cognitive decline across the overall patient population, with the most significant improvements noted in patients with mild dementia [2] - Approximately 25% of patients in the study exhibited amyloid co-pathology, which correlated with more pronounced cognitive decline; however, this decline was counteracted and reversed by treatment with buntanetap [2] Group 2: Mechanism and Biomarkers - The findings support Annovis's principle that neurodegenerative diseases often involve multiple neurotoxic proteins, which contribute to cognitive and functional decline [3] - Treatment with buntanetap resulted in significant cognitive improvements in Parkinson's patients with amyloid co-pathology, further validated by measurable reductions in biomarkers such as pTau217, total tau, and brain-derived tau, which are established indicators of neurodegeneration in Alzheimer's disease [3]

Core Insights - Buntanetap significantly improves cognition in Parkinson's patients, especially those with Alzheimer's co-pathology, showing a three-times greater response [1] - The treatment leads to reductions in plasma biomarkers pTau217, total tau, and brain-derived tau, indicating its potential to address cognitive decline and modify disease progression [1][4] - The findings support the need for therapies targeting multiple neurotoxic proteins, as neurodegenerative diseases often co-occur [3] Study Results - In a Phase 3 study, buntanetap halted cognitive decline in early Parkinson's patients, with the most significant improvements in those with mild dementia [2] - Approximately 25% of patients in the study exhibited amyloid co-pathology, which was associated with more pronounced cognitive decline that was counteracted by the treatment [2] Therapeutic Efficacy - Buntanetap treatment resulted in significant cognitive improvements in Parkinson's patients with amyloid co-pathology, supported by measurable reductions in established neurodegeneration biomarkers [4] - The data presented by the company is the first to explore treatment effects in Parkinson's patients with amyloid co-pathology, highlighting the drug's potential across multiple neurodegenerative diseases [5] Upcoming Presentation - Full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego from December 1-4, 2025, with further details to be announced [5] Company Overview - Annovis Bio, Inc. is focused on developing innovative therapies for neurodegenerative diseases, including Alzheimer's and Parkinson's, aiming to improve patient outcomes and quality of life [6]

Clinical Trials - Annovis' pivotal Phase 3 Alzheimer's study has fully activated all 84 clinical sites and is actively recruiting participants across the U.S.[5] - The trial has shown robust participation with a screen failure rate within expected projections, and the first patients have completed the 6-month treatment period, marking a key milestone[5] - Recent biomarker results from the Phase 2/3 AD trial indicate significant reductions in neuroinflammation and neurodegeneration after treatment with buntanetap compared to placebo[5] Financial Performance - Annovis' cash and cash equivalents increased to $15.3 million as of September 30, 2025, up from $10.6 million as of December 31, 2024[10] - Research and development expenses for the three months ending September 30, 2025, were $6.3 million, compared to $2.7 million for the same period in 2024, reflecting a 133% increase[10] - General and administrative expenses decreased to $1.1 million for the three months ending September 30, 2025, down from $1.7 million in the same period of 2024[10] - Annovis reported a net loss of $7.3 million for the three months ending September 30, 2025, compared to a net loss of $12.6 million for the same period in 2024[10] - The basic and diluted net loss per common share for the three months ending September 30, 2025, was $0.37, an improvement from $0.97 for the same period in 2024[10] Intellectual Property - The company secured comprehensive global intellectual property protection for the new crystal form of buntanetap through 2046[6] Executive Changes - Mark Guerin was appointed as CFO, enhancing the executive team during a critical phase of the company's development[10]

Financial Performance - The company reported a net loss of $7.263 million for the three months ended September 30, 2025, an improvement of $5.376 million compared to a net loss of $12.639 million in the same period of 2024[121]. - The company reported a net loss of $19.02 million for the nine months ended September 30, 2025, compared to a net loss of $18.73 million in 2024[128]. - Cash used in operating activities was $16.7 million for the nine months ended September 30, 2025, compared to $13.6 million in 2024, reflecting increased clinical trial expenses[140]. - Total operating expenses for the nine months ended September 30, 2025, were $19.99 million, slightly up from $19.96 million in 2024, with research and development expenses rising by $1.5 million[128]. Operating Expenses - Total operating expenses increased to $7.435 million in Q3 2025 from $4.388 million in Q3 2024, reflecting a rise of $3.047 million[121]. - Research and development expenses rose significantly to $6.291 million in Q3 2025, up by $3.601 million from $2.690 million in Q3 2024[121]. - General and administrative expenses decreased to $1.1 million for the three months ended September 30, 2025, down from $1.7 million in 2024, reflecting a $0.6 million reduction[124]. Capital and Funding - The company has an accumulated deficit of $153.9 million as of September 30, 2025, and expects to incur losses for the foreseeable future[117]. - The company plans to raise additional capital through public or private equity offerings, debt financings, and collaboration arrangements to fund operations and clinical trials[119]. - Cash provided by financing activities was $21.4 million for the nine months ended September 30, 2025, primarily from a public offering, compared to $20.5 million in 2024[142]. - The company completed a public offering in February 2025, raising gross proceeds of $21.0 million, with net proceeds of $19.3 million[136]. - As of September 30, 2025, the company had cash and cash equivalents totaling $15.3 million, which is not expected to be sufficient to fund operations for the next twelve months[135]. Clinical Trials and Research - The Phase 3 PD Study was completed on December 4, 2023, with topline efficacy data released on July 2, 2024, showing significant cognitive improvements in 12% of patients with pre-existing cognitive issues[109]. - The Phase 2/3 AD Study was completed on February 13, 2024, with topline efficacy data indicating statistically significant improvements in cognition for early AD patients[110]. - The company initiated a pivotal Phase 3 trial for early AD patients in February 2025, which includes a 6-month treatment period followed by an additional 12 months[112]. - The FDA has aligned with the company on a development path for buntanetap towards filing New Drug Applications (NDAs) for both short-term and long-term efficacy[111]. - The company believes it is the only one developing a drug that targets multiple neurotoxic proteins, potentially addressing significant unmet needs in the AD and PD markets[116]. Interest Income - Interest income increased to $0.2 million for the three months ended September 30, 2025, compared to $0.1 million in 2024, driven by higher cash balances from a public offering[125]. Future Outlook - The company expects elevated operating cash burn due to ongoing development costs associated with its active Phase 3 trial for AD[141].

Core Insights - Annovis Bio, Inc. is making significant progress in its pivotal Phase 3 Alzheimer's study, with all 84 clinical sites fully activated and participant recruitment ongoing [6][2] - The company has strengthened its intellectual property by transferring all patents to a new crystalline form of its drug, buntanetap, and published pharmacokinetic data supporting this transition [2][6] - Recent biomarker findings from a Phase 2/3 study indicate meaningful reductions in inflammation and neurodegeneration, suggesting the drug's potential as a disease-modifying therapy [2][6] Clinical Highlights - The pivotal Phase 3 study for early Alzheimer's disease is on track, with robust participation and a screen failure rate within expected projections [6] - The first patients have completed the 6-month treatment period, marking a key milestone for upcoming symptomatic readouts [6] - Biomarker results from the Phase 2/3 trial show significant reductions in neuroinflammation and neurodegeneration in patients treated with buntanetap compared to placebo [6] Business Highlights - The company appointed Mark Guerin as CFO, enhancing its leadership team during a critical phase [2][6] - Annovis presented four scientific posters at the AAIC 2025 conference, showcasing progress in its Alzheimer's trial and pharmacokinetics of buntanetap [6] Financial Results - As of September 30, 2025, Annovis reported cash and cash equivalents of $15.3 million, an increase from $10.6 million at the end of 2024 [6] - Research and development expenses for Q3 2025 were $6.3 million, up from $2.7 million in Q3 2024 [6] - The net loss per common share for Q3 2025 was $0.37, a decrease from $0.97 in Q3 2024 [7][15]