Enrollment will begin in January 2026 Participants will be treated with buntanetap for 36 months The study aims to enroll 500 patients MALVERN, Pa., Dec. 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 it will begin an Open-Label Extension (OLE) study in January 2026 to evaluate ...

MALVERN, Pa., Dec. 16, 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 it will host a corporate update webinar followed by a live Q&A session. The webinar will feature Maria Maccecchini, Ph.D., President and CEO, who will provide an overview of the Company’s recent progress, ongoing ...

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]

MALVERN, Pa., Nov. 24, 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 two presentations at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place December 1-4, 2025 in San Diego, California. The presentations will highlight progress across the Alzheimer’s an ...

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 ...

Small Cap Annovis Bio Inc. (NYSE:ANVS) stock is trading higher on Monday, with a session volume of 12.29 million compared to the average volume of 615.12 thousand as per data from Benzinga Pro.A late-stage clinical drug platform company focused on neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease, revealed new data demonstrating the impact of amyloid co-pathology on cognitive outcomes in Parkinson’s patients and the therapeutic efficacy of buntanetap.In the Phase 3 study in earl ...

Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical development MALVERN, Pa., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, I ...

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]