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ANVS

Annovis BioF
NYSE / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-14
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Investor releaseQuarter not tagged2026-08-14

Annovis Provides Corporate Updates and Second Quarter 2026 Financial Results

GlobeNewswire
Pivotal Phase 3 Alzheimer’s disease (AD) trial is fully enrolled with a total number of 850 patients, exceeding original projections. Parkinson’s disease (PD) open-label extension (OLE) study has enrolled 266 patients with full enrollment projected in Q4 2026. Annovis will host a corporate update webinar on Wednesday, September 2, 2026, at 4:00 pm EDT. MALVERN, Pa., Aug. 14, 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 provided business updates and reported financial results for the second quarter ended June 30, 2026. “Our company witnessed major clinical strides during the second quarter,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “We reached an important milestone – full enrollment of our pivotal Phase 3 study in early AD – having recruited 850 patients. This number tells us how urgently patients and families need new options and underscores their faith in our approach to treating AD. We also plan to continue the ongoing study with an open-label extension (OLE) so AD patients can continue buntanetap treatment after finishing the trial. With topline data on track for early 2027, our team has already begun preparing for regulatory submission so that we are ready to move once the results are in hand.” Clinical highlights Alzheimer’s disease – pivotal Phase 3 trial Enrollment: The trial is fully enrolled with 850 patients, exceeding the original target enrollment number of 760 patients. Patients: The pivotal Phase 3 AD trial includes patients diagnosed with early AD (MMSE 20-28) who are also positive for plasma pTau217 biomarker, confirming the presence of amyloid and tau pathology in the brain. Study design: The study measures cognition (ADAS-Cog13) and function (ADCS-iADL) as co-primary endpoints, supported by volumetric MRI, pTau217, and other biomarkers to evaluate changes in disease pathology. The study is designed to test both symptomatic (6 months) and disease-modifying (18 months) effects of buntanetap. Timeline: The Company plans a database lock for the 6-month analysis in Q1 2027, with the top-line symptomatic data readout anticipated in the same quarter. The disease-modifying data readout i…Read full document

Pivotal Phase 3 Alzheimer’s disease (AD) trial is fully enrolled with a total number of 850 patients, exceeding original projections. Parkinson’s disease (PD) open-label extension (OLE) study has enrolled 266 patients with full enrollment projected in Q4 2026. Annovis will host a corporate update webinar on Wednesday, September 2, 2026, at 4:00 pm EDT. MALVERN, Pa., Aug. 14, 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 provided business updates and reported financial results for the second quarter ended June 30, 2026. “Our company witnessed major clinical strides during the second quarter,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “We reached an important milestone – full enrollment of our pivotal Phase 3 study in early AD – having recruited 850 patients. This number tells us how urgently patients and families need new options and underscores their faith in our approach to treating AD. We also plan to continue the ongoing study with an open-label extension (OLE) so AD patients can continue buntanetap treatment after finishing the trial. With topline data on track for early 2027, our team has already begun preparing for regulatory submission so that we are ready to move once the results are in hand.” Clinical highlights Alzheimer’s disease – pivotal Phase 3 trial Enrollment: The trial is fully enrolled with 850 patients, exceeding the original target enrollment number of 760 patients. Patients: The pivotal Phase 3 AD trial includes patients diagnosed with early AD (MMSE 20-28) who are also positive for plasma pTau217 biomarker, confirming the presence of amyloid and tau pathology in the brain. Study design: The study measures cognition (ADAS-Cog13) and function (ADCS-iADL) as co-primary endpoints, supported by volumetric MRI, pTau217, and other biomarkers to evaluate changes in disease pathology. The study is designed to test both symptomatic (6 months) and disease-modifying (18 months) effects of buntanetap. Timeline: The Company plans a database lock for the 6-month analysis in Q1 2027, with the top-line symptomatic data readout anticipated in the same quarter. The disease-modifying data readout is expected a year later. Alzheimer’s disease – OLE study Start: The AD OLE study is expected to initiate in October 2026. Aim and patients: The AD OLE study will allow patients who are currently in the pivotal Phase 3 trial to receive buntanetap after completing their 18-month treatment period. Patients from both arms – buntanetap and placebo – will be allowed to join. The initiation of the AD OLE is timed to coincide with the first patient finishing their 18-month treatment, ensuring seamless transition into the extension study. The AD OLE will also be open to participants from Annovis’ prior AD clinical trials. Parkinson’s disease – OLE study Enrollment: The study has so far enrolled 266 patients toward its estimated enrollment goal of 500. It accepts participants who were in prior Annovis’ clinical trials as well as new patients who have deep brain stimulation (DBS). Site activation: 26 clinical sites have been activated across the US. Study design: The PD OLE study is designed to evaluate buntanetap's safety and long-term efficacy over the period of 36 months, supported by NeuroRPM, a real-time digital biomarker that measures core PD symptoms, and a skin biopsy test for alpha-synuclein pathology. Corporate highlights Management: Annovis promoted Cheng Fang, Ph.D., to Chief Scientific Officer (CSO), where she will oversee the clinical execution and scientific advancement of buntanetap as the Company approaches key regulatory milestones. Upcoming milestones Corporate webinar: Annovis will host a corporate update webinar on Wednesday, September 2, 2026, at 4:00 pm EDT. To participate, please register using the following link: Annovis Webinar - Corporate Update Questions: Participants are encouraged to submit questions in advance to [email protected] Financial results Annovis’ cash and cash equivalents totaled $18.7 million as of June 30, 2026, compared to $19.5 million as of December 31, 2025. Annovis had 42.6 million shares of common stock outstanding as of June 30, 2026. Research and development expenses for the three months ended June 30, 2026, were $12.0 million compared to $5.2 million for the three months ended June 30, 2025. General and administrative expenses for the three months ended June 30, 2026, were $2.4 million compared to $1.1 million for the three months ended June 30, 2025. Annovis reported a $0.40 basic and diluted net loss per common share for the three months ended June 30, 2026, compared to a $0.32 basic and diluted net loss per common share for the three months ended June 30, 2025. About AnnovisHeadquartered 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. 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 AlertsInterested 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 StatementsThis 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 DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis [email protected] (Tables to follow)

Investor releaseQuarter not tagged2026-05-15

Annovis Provides Corporate Updates and Reports First Quarter 2026 Financial Results

GlobeNewswire
Phase 3 AD trial: 85% of patients enrolled; full enrollment on track in summer 2026 PD open-label extension (OLE) study: 40% of patients enrolled; full enrollment on track in fourth quarter 2026 New Drug Application (NDA) for buntanetap as a symptomatic treatment for AD is expected in early 2027 and as a potential disease-modifying treatment in early 2028 MALVERN, Pa., May 15, 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 provided business updates and reported financial results for the first quarter ended March 31, 2026. "We saw strong momentum across both our AD and PD programs in the first quarter," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “Our Phase 3 AD clinical trial achieved significant enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026 and deliver first top-line results in early 2027. Simultaneously, we launched a PD OLE study and have been encouraged by the robust interest from both returning and new patients. This year is pivotal: we expect to generate substantive clinical data across both indications that will anchor our regulatory path toward an NDA submission for buntanetap." Clinical highlights Alzheimer’s disease – pivotal Phase 3 trial (NCT06709014) Enrollment: 85% of patients enrolled. Screening: On May 15, 2026, Annovis closed enrollment to new participants after reaching a sufficient number of patients in screening to meet the trial's enrollment goal. Safety: Annovis received a positive recommendation from the Data and Safety Monitoring Board (DSMB) regarding the drug’s safety at 6 months, supporting seamless continuation of the study. Study design: The pivotal Phase 3 AD trial is recruiting early AD patients positive for pTau217 plasma biomarker. The study is designed to evaluate buntanetap's symptomatic effect at 6 months and its potential disease-modifying effect at 18 months. Parkinson’s disease – OLE study (NCT07284784) Enrollment: 40% of patients enrolled. Skin biomarker: The PD OLE study is implementing a biomarker test measuring levels of phosphorylated alpha-synuclein and nerve cell fiber density via skin biopsy. Digital biom…Read full document

Phase 3 AD trial: 85% of patients enrolled; full enrollment on track in summer 2026 PD open-label extension (OLE) study: 40% of patients enrolled; full enrollment on track in fourth quarter 2026 New Drug Application (NDA) for buntanetap as a symptomatic treatment for AD is expected in early 2027 and as a potential disease-modifying treatment in early 2028 MALVERN, Pa., May 15, 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 provided business updates and reported financial results for the first quarter ended March 31, 2026. "We saw strong momentum across both our AD and PD programs in the first quarter," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “Our Phase 3 AD clinical trial achieved significant enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026 and deliver first top-line results in early 2027. Simultaneously, we launched a PD OLE study and have been encouraged by the robust interest from both returning and new patients. This year is pivotal: we expect to generate substantive clinical data across both indications that will anchor our regulatory path toward an NDA submission for buntanetap." Clinical highlights Alzheimer’s disease – pivotal Phase 3 trial (NCT06709014) Enrollment: 85% of patients enrolled. Screening: On May 15, 2026, Annovis closed enrollment to new participants after reaching a sufficient number of patients in screening to meet the trial's enrollment goal. Safety: Annovis received a positive recommendation from the Data and Safety Monitoring Board (DSMB) regarding the drug’s safety at 6 months, supporting seamless continuation of the study. Study design: The pivotal Phase 3 AD trial is recruiting early AD patients positive for pTau217 plasma biomarker. The study is designed to evaluate buntanetap's symptomatic effect at 6 months and its potential disease-modifying effect at 18 months. Parkinson’s disease – OLE study (NCT07284784) Enrollment: 40% of patients enrolled. Skin biomarker: The PD OLE study is implementing a biomarker test measuring levels of phosphorylated alpha-synuclein and nerve cell fiber density via skin biopsy. Digital biomarker: Annovis entered into a partnership with NeuroRPM to integrate an AI-powered digital biomarker, enabling continuous, real-world assessment of motor functions in response to buntanetap. Study design: The PD OLE study is designed to evaluate buntanetap's safety and long-term efficacy over the period of 36 months in participants from prior Annovis’ trials as well as in new patients who had deep brain stimulation (DBS) surgery. Corporate highlights Publications Annovis published a byline article in The Scientist, tracing the 170-year scientific history of buntanetap, from the origins of its predecessor compound to its mechanism of action and key events that shaped the drug’s clinical development. Annovis announced a peer-reviewed publication of the Phase 2/3 AD clinical trial results in Nature NPJ Dementia, available open access, demonstrating a dose-dependent cognitive improvement and biomarker reductions in patients treated with buntanetap. Presentations Cheng Fang, Ph.D., SVP, R&D, presented two posters at the AD/PD2026 conference, highlighting clinical data which support buntanetap's treatment effect in PD with a particular focus on cognition and biomarker findings as well as an update on the ongoing pivotal Phase 3 AD trial. Maria Maccecchini, Ph.D., President and CEO, presented at Fierce Biotech Week 2026 in Boston, delivering a talk titled "The Multi-Protein Reality of Alzheimer's Disease: What the Science Has Known for Decades and What the Field Has Yet to Accept," making the scientific case for targeting multiple neurotoxic proteins in AD and presenting buntanetap's clinical evidence of cognitive and biomarker improvements. Patents Annovis secured a U.S. patent, covering prevention and treatment of neurological injuries arising from brain infections through the administration of buntanetap or related compounds. Upcoming milestones Phase 3 AD study: Annovis expects to reach full enrollment in summer 2026. The symptomatic data readout is anticipated approximately 6 months after the last patient is dosed. The disease-modifying data readout is anticipated 18 months after the last patient is dosed. PD OLE study: Annovis expects to complete enrollment for the PD OLE study in the fourth quarter of 2026. NDA pathway: Based on the Phase 3 AD study outcomes, Annovis plans to engage with the FDA regarding a regulatory NDA submission for buntanetap as a symptomatic treatment for AD in early 2027 and as a disease-modifying treatment in early 2028. Financial results Annovis’ cash and cash equivalents totaled $14.2 million as of March 31, 2026, compared to $19.5 million as of December 31, 2025. This excludes gross proceeds from its recent $10.0 million registered direct offering on April 10, 2026. Annovis had 28.5 million shares of common stock outstanding as of March 31, 2026. Research and development expenses for the three months ended March 31, 2026, were $16.7 million compared to $5.0 million for the three months ended March 31, 2025. General and administrative expenses for the three months ended March 31, 2026, were $1.3 million compared to $1.3 million for the three months ended March 31, 2025. Annovis reported a $0.63 basic and diluted net loss per common share for the three months ended March 31, 2026, compared to a $0.32 basic and diluted net loss per common share for the three months ended March 31, 2025. 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] (Tables to follow)

Investor releaseQuarter not tagged2026-04-28

Annovis Publishes Phase 2/3 Alzheimer's Trial Results in Nature Portfolio

GlobeNewswire
Buntanetap improved cognition in pTau217-positive early AD patients The drug reduced neurotoxic proteins as well as biomarkers of neuroinflammation and neurodegeneration Buntanetap was safe and well-tolerated, including in ApoE4 carriers Phase 2/3 findings support ongoing pivotal Phase 3 study in early AD, with 80% patients enrolled to date MALVERN, Pa., April 28, 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 new publication titled “Buntanetap treatment in mild to moderate Alzheimer’s disease: phase 2/3 study” in a peer-reviewed journal Nature NPJ Dementia. The Phase 2/3 study (NCT05686044) was a randomized, double-blinded, placebo-controlled trial evaluating three doses of buntanetap (7.5 mg, 15 mg, and 30 mg) over 12 weeks in 351 patients with mild to moderate AD. The study demonstrated that buntanetap was safe and well-tolerated across all disease stages and dose levels. Notably, safety was also assessed in ApoE4 carriers, the most genetically at-risk population for AD, with no increase in adverse events compared to non-carriers and to placebo. Given buntanetap's distinct mechanism of action, the drug was also well-tolerated when taken alongside approved symptomatic therapies, allowing patients to maintain their existing medication regimens without the need for discontinuation. Study analyses revealed statistically significant, dose-dependent improvements in cognition, as measured by ADAS-Cog11, in pTau217 biomarker-positive patients with mild AD (MMSE 21–24). Moreover, at the 30 mg dose, buntanetap demonstrated a consistent treatment effect across all analyzed patient groups when stratified by age, body mass index, sex, ethnicity, ApoE4 carrier status, and concomitant medication use, with favorable effects versus placebo observed across each of these groups. Biomarker analyses further revealed reductions in neurotoxic proteins TDP-43 and tau, in the markers of neuroinflammation, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R, as well as in the marker of neurodegeneration, neurofilament light chain (NfL), pointing to potential disease-modifying activity. Importantly, the same trends were observed in pla…Read full document

Buntanetap improved cognition in pTau217-positive early AD patients The drug reduced neurotoxic proteins as well as biomarkers of neuroinflammation and neurodegeneration Buntanetap was safe and well-tolerated, including in ApoE4 carriers Phase 2/3 findings support ongoing pivotal Phase 3 study in early AD, with 80% patients enrolled to date MALVERN, Pa., April 28, 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 new publication titled “Buntanetap treatment in mild to moderate Alzheimer’s disease: phase 2/3 study” in a peer-reviewed journal Nature NPJ Dementia. The Phase 2/3 study (NCT05686044) was a randomized, double-blinded, placebo-controlled trial evaluating three doses of buntanetap (7.5 mg, 15 mg, and 30 mg) over 12 weeks in 351 patients with mild to moderate AD. The study demonstrated that buntanetap was safe and well-tolerated across all disease stages and dose levels. Notably, safety was also assessed in ApoE4 carriers, the most genetically at-risk population for AD, with no increase in adverse events compared to non-carriers and to placebo. Given buntanetap's distinct mechanism of action, the drug was also well-tolerated when taken alongside approved symptomatic therapies, allowing patients to maintain their existing medication regimens without the need for discontinuation. Study analyses revealed statistically significant, dose-dependent improvements in cognition, as measured by ADAS-Cog11, in pTau217 biomarker-positive patients with mild AD (MMSE 21–24). Moreover, at the 30 mg dose, buntanetap demonstrated a consistent treatment effect across all analyzed patient groups when stratified by age, body mass index, sex, ethnicity, ApoE4 carrier status, and concomitant medication use, with favorable effects versus placebo observed across each of these groups. Biomarker analyses further revealed reductions in neurotoxic proteins TDP-43 and tau, in the markers of neuroinflammation, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R, as well as in the marker of neurodegeneration, neurofilament light chain (NfL), pointing to potential disease-modifying activity. Importantly, the same trends were observed in plasma samples from patients with moderate AD, further supporting buntanetap's mechanism of action. "The publication of these results in a peer-reviewed journal marks an important step in the scientific validation of buntanetap," said Cheng Fang, Ph.D., Senior Vice President, Research & Development. "The data reinforce what we have seen across multiple studies: buntanetap addresses the underlying pathology of AD with a safety profile that supports its use in a broad, genetically diverse patient population. The treatment effect we observed in biomarker-confirmed early AD patients provides strong scientific rationale as we advance our drug candidate through a pivotal Phase 3 study." Buntanetap is currently being investigated in a pivotal Phase 3 clinical trial enrolling pTau217 biomarker-positive patients with early AD (MMSE 20–28) (NCT06709014). The trial is designed to replicate and extend the findings of the Phase 2/3 study, evaluating the efficacy of buntanetap at 6 and 18 months, measuring symptomatic and potential disease-modifying benefits, respectively. The study is nearing full enrollment, with 80% of patients already enrolled. 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]

Investor releaseQuarter not tagged2026-03-16

Annovis Provides Corporate Updates and Reports Fiscal Year 2025 Financial Results

GlobeNewswire
MALVERN, Pa., March 16, 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 business updates and reported financial results for the fiscal year 2025. In 2025, Annovis achieved a significant milestone in its clinical development program with the initiation of a pivotal Phase 3 clinical trial in early AD. The year was largely dedicated to the activation of clinical sites and the enrollment of participants across the United States. The Company also reported encouraging data from both its previous Alzheimer's and Parkinson's programs, demonstrating a potential disease-modifying signal for buntanetap through reductions in biomarkers of amyloid and tau pathology, neuroinflammation, and neurodegeneration. Building on this momentum, Annovis recently initiated an open-label extension (OLE) study in PD. "The year 2025 was a landmark period for Annovis, one in which we took decisive steps toward bringing buntanetap to patients," said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. "We initiated our pivotal Phase 3 AD study and later launched an OLE PD study, both critical milestones on the path to an NDA submission. Throughout the year, we remained focused on designing, preparing, and executing these studies with the highest standards of rigor while maintaining our scientific presence through key conferences, meetings, and publications. Equally important, we also revealed new biomarker data on buntanetap from our ongoing analysis of the completed studies, reinforcing the drug’s therapeutic potential." Clinical progress Alzheimer’s disease In February 2025, Annovis launched a pivotal Phase 3 study (NCT06709014) evaluating buntanetap over a period of 18 months as both a symptomatic (6 months) and a potential disease-modifying (18 months) treatment in early AD patients. In October 2025, Annovis announced that the first participants reached the 6-month milestone aimed at measuring the symptomatic effect of buntanetap. In October 2025, the Company also reported new biomarker data from its Phase 2/3 AD trial, demonstrating potential disease-modifying activity of buntanetap as measured by reductions in biomarkers of neurotoxic…Read full document

MALVERN, Pa., March 16, 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 business updates and reported financial results for the fiscal year 2025. In 2025, Annovis achieved a significant milestone in its clinical development program with the initiation of a pivotal Phase 3 clinical trial in early AD. The year was largely dedicated to the activation of clinical sites and the enrollment of participants across the United States. The Company also reported encouraging data from both its previous Alzheimer's and Parkinson's programs, demonstrating a potential disease-modifying signal for buntanetap through reductions in biomarkers of amyloid and tau pathology, neuroinflammation, and neurodegeneration. Building on this momentum, Annovis recently initiated an open-label extension (OLE) study in PD. "The year 2025 was a landmark period for Annovis, one in which we took decisive steps toward bringing buntanetap to patients," said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. "We initiated our pivotal Phase 3 AD study and later launched an OLE PD study, both critical milestones on the path to an NDA submission. Throughout the year, we remained focused on designing, preparing, and executing these studies with the highest standards of rigor while maintaining our scientific presence through key conferences, meetings, and publications. Equally important, we also revealed new biomarker data on buntanetap from our ongoing analysis of the completed studies, reinforcing the drug’s therapeutic potential." Clinical progress Alzheimer’s disease In February 2025, Annovis launched a pivotal Phase 3 study (NCT06709014) evaluating buntanetap over a period of 18 months as both a symptomatic (6 months) and a potential disease-modifying (18 months) treatment in early AD patients. In October 2025, Annovis announced that the first participants reached the 6-month milestone aimed at measuring the symptomatic effect of buntanetap. In October 2025, the Company also reported new biomarker data from its Phase 2/3 AD trial, demonstrating potential disease-modifying activity of buntanetap as measured by reductions in biomarkers of neurotoxic proteins, neuroinflammation, and neurodegeneration. In February 2026, Annovis received a positive recommendation from the Data and Safety Monitoring Board (DSMB) regarding buntanetap’s safety at 6 months, supporting the continuation of the trial without modifications. As of March 2026, Annovis has enrolled 65% of the target participant population for its pivotal Phase 3 AD clinical trial across 83 clinical sites in the United States. Parkinson’s disease In November 2025, Annovis reported novel biomarker data linking amyloid co-pathology in PD to accelerated cognitive decline. The data also showed that buntanetap improved cognition in these patients and reduced amyloid and tau pathology as measured by total tau, phosphorylated tau (pTau217), and brain-derived tau. In December 2025, Annovis announced an OLE study in PD (NCT07284784), which commenced in January 2026. The OLE study is currently enrolling patients from the Company’s previous PD trials as well as new participants with a stable deep brain stimulation (DBS) therapy, and it is designed to evaluate the long-term safety and tolerability of buntanetap over 36 months. The study also aims to evaluate a potential efficacy response and collect biomarker data to measure changes in disease pathology. In January 2026, following the data demonstrating significant cognitive improvements in cognitively impaired PD patients with amyloid pathology after treatment with buntanetap, Annovis met with the FDA to discuss a new study in PD dementia (PDD). The Company received a positive recommendation to proceed and is currently in discussions with the FDA to determine the trial design and endpoints for its execution. Buntanetap development In August 2025, Annovis announced the transfer of all Company’s patents to the new crystal form of buntanetap. This new form offers improved solid-state stability while preserving the drug’s pharmacokinetic profile. This transfer also extends the intellectual property protection for buntanetap – covering composition of matter, mechanism of action, applications of buntanetap for multiple indications, and its combination with other drugs – until 2047. As of year-end 2025, Annovis held a total of 40 granted patents and 48 patent applications. Most granted patents have received approval across major global markets, and all patent applications have been or are being filed worldwide. In September 2025, Annovis announced a publication in a peer-reviewed journal Biomolecules describing the new crystal form of buntanetap, its pharmacokinetics, and comparison to the original form. The new crystal form is now used in the ongoing clinical trials – pivotal Phase 3 AD study and OLE PD study – and will be used in any future Company’s trials. Business highlights In 2025, Annovis' leadership participated in key scientific conferences, including the Drug Development Summit focused on innovative PD treatments; AD/PD 2025, where the Company delivered two presentations and participated in a forum discussion; the Alzheimer's Association International Conference (AAIC) 2025, with four presentations; the Reuters Event: Pharma Clinical Innovation USA 2025; the Clinical Trials on Alzheimer's Disease (CTAD) conference, with two presentations; and the 2025 Annual Meeting of the Parkinson's Study Group. Annovis also presented at major investor conferences, including the Oppenheimer 34th Annual Healthcare Life Sciences Conference and the H.C. Wainwright 27th Annual Global Investment Conference. Additionally, the Company hosted several webinars, including corporate update and patient webinars, where the management team provided updates on the clinical trial progress and answered live questions from the audience. Management highlights In 2025, Annovis expanded its core management team by appointing Mark Guerin as CFO and Hui Liu as Director of Biostatistics. Mark Guerin, CPA, CMA, CFM, Annovis' CFO, has an extensive background in biopharma financial operations, including financial reporting, forecasting, internal controls, IPOs, follow-on offerings, and acquisitions and divestitures. Hui Liu, Director of Biostatistics, has an extensive experience in statistical methodology and analysis, design and reporting of all phases of clinical trials, and interpreting complex data to support regulatory submissions. Financial results Research and development expenses for the year ended December 31, 2025 were $25.2 million compared to $20.0 million for the year ended December 31, 2024. General and administrative expenses for the year ended December 31, 2025 were $4.5 million compared to $6.7 million for the year ended December 31, 2024. Annovis reported a $1.40 basic and $1.40 diluted net loss per common share for the year ended December 31, 2025 on 20.6 million weighted-average common shares outstanding, compared to a $2.02 basic and $2.31 diluted net loss per common share for the year ended December 31, 2024 on 12.2 million weighted-average common shares outstanding. Annovis’ cash and cash equivalents totaled $19.5 million as of December 31, 2025 compared to $10.6 million as of December 31, 2024. The Company estimates that its current cash and cash equivalents, including proceeds from its stock offerings in the fourth quarter of 2025, will enable it to fund its operations into the third quarter of 2026. The Company had 27.2 million shares of common stock outstanding as of December 31, 2025. 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] (Tables to follow) ANNOVIS BIO, INC. Balance Sheets ANNOVIS BIO, INC. Statements of Operations

Investor releaseQuarter not tagged2025-11-12

Annovis Provides Corporate Updates and Reports Third Quarter 2025 Financial Results

GlobeNewswire
MALVERN, Pa., Nov. 12, 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 provided corporate updates and third quarter 2025 financial results. "The past quarter delivered breakthrough progress on every front," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our pivotal Phase 3 Alzheimer's study has achieved full activation across all clinical sites, with enrollment momentum advancing every day. We have fortified our intellectual property position by transferring all patents to our new crystal form of buntanetap while publishing compelling pharmacokinetic data that validates this milestone. The addition of a seasoned CFO strengthens our executive team precisely when it matters most. Adding to all this, we are particularly encouraged by the new biomarker findings from our Phase 2/3 study showing meaningful reductions in inflammation and neurodegeneration—powerful evidence of buntanetap's disease-modifying potential. Every element is now aligned as we move toward our data readouts—the final step before an NDA submission." Clinical highlights – pivotal Phase 3 AD study Annovis’ pivotal Phase 3 study in early AD (NCT06709014) remains on track, with all 84 clinical sites fully activated, recruiting, and treating participants across the U.S. The trial has generated robust participation, reflecting growing enthusiasm from the patient community. The screen failure rate remains within expected projections. The first patients have successfully completed the 6-month treatment period, a key milestone for the upcoming symptomatic readout, reinforcing steady progress toward trial completion. Business highlights In October, Annovis announced encouraging biomarker results from its Phase 2/3 AD trial, showing profound reductions in key markers of neuroinflammation and neurodegeneration after treatment with buntanetap compared to placebo. The effect was observed in patients with mild and moderate stages of the disease. These findings further validate the drug’s ability to halt the toxic cascade and reinforce its potential as a potential disease-modifying therapy. In September, Annovis published a new peer-reviewed article highlighting the pharmacokinet…Read full document

MALVERN, Pa., Nov. 12, 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 provided corporate updates and third quarter 2025 financial results. "The past quarter delivered breakthrough progress on every front," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our pivotal Phase 3 Alzheimer's study has achieved full activation across all clinical sites, with enrollment momentum advancing every day. We have fortified our intellectual property position by transferring all patents to our new crystal form of buntanetap while publishing compelling pharmacokinetic data that validates this milestone. The addition of a seasoned CFO strengthens our executive team precisely when it matters most. Adding to all this, we are particularly encouraged by the new biomarker findings from our Phase 2/3 study showing meaningful reductions in inflammation and neurodegeneration—powerful evidence of buntanetap's disease-modifying potential. Every element is now aligned as we move toward our data readouts—the final step before an NDA submission." Clinical highlights – pivotal Phase 3 AD study Annovis’ pivotal Phase 3 study in early AD (NCT06709014) remains on track, with all 84 clinical sites fully activated, recruiting, and treating participants across the U.S. The trial has generated robust participation, reflecting growing enthusiasm from the patient community. The screen failure rate remains within expected projections. The first patients have successfully completed the 6-month treatment period, a key milestone for the upcoming symptomatic readout, reinforcing steady progress toward trial completion. Business highlights In October, Annovis announced encouraging biomarker results from its Phase 2/3 AD trial, showing profound reductions in key markers of neuroinflammation and neurodegeneration after treatment with buntanetap compared to placebo. The effect was observed in patients with mild and moderate stages of the disease. These findings further validate the drug’s ability to halt the toxic cascade and reinforce its potential as a potential disease-modifying therapy. In September, Annovis published a new peer-reviewed article highlighting the pharmacokinetics (PK) of the novel crystalline form of buntanetap and its comparison to the original form. The study, which included data from mice, dogs, and humans, demonstrated a better solid-state stability of the new form while preserving its PK profile and metabolism. The article was published following the Company's announcement that all patents have been successfully transferred to the new crystal form, securing comprehensive global intellectual property protection through 2046. That same month, Annovis strengthened its leadership team with the appointment of Mark Guerin as CFO, a seasoned executive with a proven track record in driving financial strategy and operational excellence across biopharma organizations. In August, Annovis’ management attended the AAIC 2025 conference in Toronto, where it presented four scientific posters, covering the progress of its Phase 3 Alzheimer’s trial and PK characterization of buntanetap. Financial results Annovis’ cash and cash equivalents totaled $15.3 million as of September 30, 2025, compared to $10.6 million as of December 31, 2024. This includes gross proceeds from its recent $6.0 million and $3.4 million registered direct offerings in October, enabling the Company to fund its operations to the third quarter of 2026. Annovis had 20.2 million shares of common stock outstanding as of September 30, 2025. Research and development expenses for the three months ending September 30, 2025, were $6.3 million compared to $2.7 million for the three months ending September 30, 2024. General and administrative expenses for the three months ending September 30, 2025, were $1.1 million compared to $1.7 million for the three months ending September 30, 2024. Annovis reported a $0.37 basic and diluted net loss per common share for the three months ending September 30, 2025, compared to a $0.97 basic and diluted net loss per common share for the three months ending September 30, 2024. About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. 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] (Tables to follow)

Investor releaseQuarter not tagged2025-08-13

Annovis Provides Corporate Updates and Reports Second Quarter 2025 Financial Results

GlobeNewswire
MALVERN, Pa., Aug. 12, 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 provided corporate updates and second quarter 2025 financial results. “In the past quarter, our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD, which now includes 76 secured clinical sites across the U.S. and over 400 patients screened to date,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “At the same time, we reached other notable milestones, including presenting our latest scientific findings at AAIC 2025 with the largest attendance ever from Annovis team and strengthening our global intellectual property protection by completing the transfer of all patent families to crystal buntanetap. As we move forward, our focus stays firmly on completing enrollment as planned to produce strong and trustworthy results, while also advancing our Parkinson’s program, with more updates coming as we progress.” Clinical highlights Annovis’ pivotal Phase 3 study in early AD (NCT06709014) is advancing rapidly, with 76 U.S. sites secured and 46 currently enrolling patients. The remaining sites are expected to begin enrollment shortly. The pivotal Phase 3 trial has attracted strong participation, with 38 patients already receiving buntanetap or placebo and nearly 200 more in screening – a number that continues to grow each day – with screen failure rate being as expected at 50%. Business highlights In April, Annovis welcomed Hui Liu as Director of Biostatistics, who is responsible for maintaining statistical integrity of the data generated by the Company’s clinical trials. In June, Annovis hosted a webcast to provide updates on its Phase 3 trial, engaging directly with the audience through a live Q&A session. The recording is available in the Video Library on the Company’s website. In July, senior members of Annovis attended AAIC 2025 in Toronto, presenting four scientific posters highlighting advancements in the Alzheimer’s Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap. All posters are available in the Media Library on the Company’s website. In August, Annovis announced the successful transfer of all…Read full document

MALVERN, Pa., Aug. 12, 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 provided corporate updates and second quarter 2025 financial results. “In the past quarter, our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD, which now includes 76 secured clinical sites across the U.S. and over 400 patients screened to date,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “At the same time, we reached other notable milestones, including presenting our latest scientific findings at AAIC 2025 with the largest attendance ever from Annovis team and strengthening our global intellectual property protection by completing the transfer of all patent families to crystal buntanetap. As we move forward, our focus stays firmly on completing enrollment as planned to produce strong and trustworthy results, while also advancing our Parkinson’s program, with more updates coming as we progress.” Clinical highlights Annovis’ pivotal Phase 3 study in early AD (NCT06709014) is advancing rapidly, with 76 U.S. sites secured and 46 currently enrolling patients. The remaining sites are expected to begin enrollment shortly. The pivotal Phase 3 trial has attracted strong participation, with 38 patients already receiving buntanetap or placebo and nearly 200 more in screening – a number that continues to grow each day – with screen failure rate being as expected at 50%. Business highlights In April, Annovis welcomed Hui Liu as Director of Biostatistics, who is responsible for maintaining statistical integrity of the data generated by the Company’s clinical trials. In June, Annovis hosted a webcast to provide updates on its Phase 3 trial, engaging directly with the audience through a live Q&A session. The recording is available in the Video Library on the Company’s website. In July, senior members of Annovis attended AAIC 2025 in Toronto, presenting four scientific posters highlighting advancements in the Alzheimer’s Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap. All posters are available in the Media Library on the Company’s website. In August, Annovis announced the successful transfer of all patent families to crystal buntanetap, achieving comprehensive global IP coverage for both the original and new forms of the Company’s drug candidate. Financial results Annovis’ cash and cash equivalents totaled $17.1 million as of June 30, 2025, compared to $10.6 million as of December 31, 2024. The Company had 19.5 million shares of common stock outstanding as of June 30, 2025. Research and development expenses for the three months ending June 30, 2025, were $5.2 million compared to $5.8 million for the three months ending June 30, 2024. General and administrative expenses for the three months ending June 30, 2025, were $1.1 million compared to $2.0 million for the three months ending June 30, 2024. Annovis reported a $0.32 basic and diluted net loss per common share for the three months ending June 30, 2025, compared to a $0.44 basic and diluted net loss per common share for the three months ending June 30, 2024. About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. 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] (Tables to follow)

Investor releaseQuarter not tagged2025-05-14

Annovis Provides Corporate Updates and Reports First Quarter 2025 Financial Results

GlobeNewswire
Malvern, Pa., May 13, 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 provided corporate updates and first quarter 2025 financial results. The first quarter was largely dedicated to the initiation of a pivotal Phase 3 clinical trial in early AD, with the first participants entering the study on February 5, 2025. The trial is currently in the process of activating clinical sites across the U.S. and enrolling patients with the goal of treating an estimated 760 participants with either buntanetap or placebo. This dual 6/18-month pivotal Phase 3 study will evaluate the symptomatic benefits of buntanetap during the first 6 months and its potential disease-modifying effects over the subsequent 12 months. In addition, the first quarter was marked by active conference participation from Annovis senior management. “We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day,” said Melissa Gaines, SVP, Clinical Operations. “Our team is grateful to all collaborators for helping make this process efficient and to our community for their ongoing support. We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.” “In these times of great uncertainty, we are choosing resilience and discipline, putting one foot in front of the other as we stay focused on advancing the Phase 3 AD study,” added Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “Our mission remains clear: to deliver a potentially life-changing treatment to patients as soon as possible.” Business highlights In January, Annovis was granted a U.S. patent covering methods for the treatment and prevention of acute brain and nerve injuries using buntanetap. In February, Annovis participated in Oppenheimer’s 35th Annual Healthcare Life Sciences Conference, which brought together leading innovators and investors in the healthcare sector. In February and March, Annovis’ management team participated in several key scientific conferences focused on neurodegenerative diseases. At AD/PDTM 2025 in Vienna, Annovis gave two presentations, showcasing findings from its Phase 3 PD trial and data on bu…Read full document

Malvern, Pa., May 13, 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 provided corporate updates and first quarter 2025 financial results. The first quarter was largely dedicated to the initiation of a pivotal Phase 3 clinical trial in early AD, with the first participants entering the study on February 5, 2025. The trial is currently in the process of activating clinical sites across the U.S. and enrolling patients with the goal of treating an estimated 760 participants with either buntanetap or placebo. This dual 6/18-month pivotal Phase 3 study will evaluate the symptomatic benefits of buntanetap during the first 6 months and its potential disease-modifying effects over the subsequent 12 months. In addition, the first quarter was marked by active conference participation from Annovis senior management. “We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day,” said Melissa Gaines, SVP, Clinical Operations. “Our team is grateful to all collaborators for helping make this process efficient and to our community for their ongoing support. We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.” “In these times of great uncertainty, we are choosing resilience and discipline, putting one foot in front of the other as we stay focused on advancing the Phase 3 AD study,” added Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “Our mission remains clear: to deliver a potentially life-changing treatment to patients as soon as possible.” Business highlights In January, Annovis was granted a U.S. patent covering methods for the treatment and prevention of acute brain and nerve injuries using buntanetap. In February, Annovis participated in Oppenheimer’s 35th Annual Healthcare Life Sciences Conference, which brought together leading innovators and investors in the healthcare sector. In February and March, Annovis’ management team participated in several key scientific conferences focused on neurodegenerative diseases. At AD/PDTM 2025 in Vienna, Annovis gave two presentations, showcasing findings from its Phase 3 PD trial and data on buntanetap in ApoE4 carriers from its Phase 2/3 AD study. The Company also participated in a forum on the development of alpha-synuclein treatments. Additionally, at Alzheimer’s Partnering Summit and at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit, Dr. Maccecchini presented and contributed to discussions on clinical advancements in AD and PD and on approaches to targeting alpha-synuclein. Financial results Annovis’ cash and cash equivalents totaled $22.2 million as of March 31, 2025, compared to $10.6 million as of March 31, 2024. The Company had 19.5 million shares of common stock outstanding as of March 31, 2025. Research and development expenses for the three months ended March 31, 2025, were $5.0 million compared to $6.5 million for the three months ended March 31, 2024. General and administrative expenses for the three months ended March 31, 2025, were $1.3 million compared to $1.3 million for the three months ended March 31, 2024. Annovis reported a $0.32 basic and $0.32 diluted net loss per common share for the three months ended March 31, 2025, compared to a $0.10 basic and $0.72 diluted net loss per common share for the three months ended March 31, 2024. About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested 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 StatementsThis 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 DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis [email protected] (Tables to follow)

Investor releaseQuarter not tagged2025-03-22

Annovis Provides Corporate Updates and Reports Fourth Quarter and Fiscal Year 2024 Financial Results

GlobeNewswire
MALVERN, Pa., March 21, 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 provided corporate updates and fourth quarter/full year 2024 financial results. In 2024, Annovis made significant progress by advancing the buntanetap program, successfully completing two clinical trials—Phase 2/3 AD and Phase 3 PD. Both studies yielded promising results, reinforcing buntanetap’s ability to improve cognition in AD and PD patients, as well as motor function in PD patients. Building on this success, the FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, which was launched at the start of 2025. The Company also participated in multiple scientific and investor conferences, announced new publications in peer-reviewed journals, expanded its patent portfolio, and added accomplished professionals to its growing team. “The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025,” said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “We are deeply grateful to everyone who has supported and believed in our mission. As we move ahead, our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.” Clinical progress In October 2024, the FDA granted clearance to proceed with a pivotal Phase 3 study for early AD, based on Phase 2/3 clinical data demonstrating symptomatic improvement in the subgroup of early AD patients. In February 2025, Annovis launched the pivotal Phase 3 AD study, which includes a 6-month data readout focused on buntanetap’s symptomatic effects followed by an additional 12-month assessment to evaluate its potential disease-modifying response. The symptomatic data is anticipated in mid-2026, followed by the disease-modifying data in mid-2027, with both expected to support their respective New Drug Applications (NDAs). Business highlights In October 2024, Annovis appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist. In this role, Dr. Peterson ensures the medical, ethical, and scientific integrity of Annovis’ clinical trials, overseeing their initiation, execution, reporting, and successful c…Read full document

MALVERN, Pa., March 21, 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 provided corporate updates and fourth quarter/full year 2024 financial results. In 2024, Annovis made significant progress by advancing the buntanetap program, successfully completing two clinical trials—Phase 2/3 AD and Phase 3 PD. Both studies yielded promising results, reinforcing buntanetap’s ability to improve cognition in AD and PD patients, as well as motor function in PD patients. Building on this success, the FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, which was launched at the start of 2025. The Company also participated in multiple scientific and investor conferences, announced new publications in peer-reviewed journals, expanded its patent portfolio, and added accomplished professionals to its growing team. “The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025,” said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “We are deeply grateful to everyone who has supported and believed in our mission. As we move ahead, our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.” Clinical progress In October 2024, the FDA granted clearance to proceed with a pivotal Phase 3 study for early AD, based on Phase 2/3 clinical data demonstrating symptomatic improvement in the subgroup of early AD patients. In February 2025, Annovis launched the pivotal Phase 3 AD study, which includes a 6-month data readout focused on buntanetap’s symptomatic effects followed by an additional 12-month assessment to evaluate its potential disease-modifying response. The symptomatic data is anticipated in mid-2026, followed by the disease-modifying data in mid-2027, with both expected to support their respective New Drug Applications (NDAs). Business highlights In October 2024, Annovis appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist. In this role, Dr. Peterson ensures the medical, ethical, and scientific integrity of Annovis’ clinical trials, overseeing their initiation, execution, reporting, and successful completion. In October and November 2024, Annovis’ leadership participated in key scientific conferences in the neurodegenerative disease space. At the 7th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Annovis presented two posters highlighting findings from its Phase 2/3 AD trial and related biomarker data. Additionally, Annovis was invited to speak at the NIA/NINDS Workshop on Dementia with Lewy Bodies (DLB), where it presented buntanetap’s distinctive mechanism of action and its potential as a treatment for DLB. In December 2024, Annovis hosted a year-end webcast, where management addressed key questions from shareholders and provided updates on the Company’s clinical progress and upcoming milestones. Financial results Fourth quarter – Research and development expenses for the three months ended December 31, 2024, were $5.0 million compared to $8.9 million for the three months ended December 31, 2023. General and administrative expenses for the three months ended December 31, 2024, were $1.7 million compared to $1.5 million for the three months ended December 31, 2023. Annovis reported a $0.43 basic and diluted net loss per common share for the three months ended December 31, 2024, compared to a $2.24 basic and diluted net loss per common share for the three months ended December 31, 2023. Full year – Research and development expenses for the year ended December 31, 2024, were $20.0 million compared to $38.8 million for the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024, were $6.7 million compared to $6.2 million for the year ended December 31, 2023. Annovis reported a $2.02 basic and $2.31 diluted net loss per common share for the year ended December 31, 2024, compared to a $6.23 basic and diluted net loss per common share for the year ended December 31, 2023. Annovis’ cash and cash equivalents totaled $10.6 million as of December 31, 2024, compared to $5.8 million as of December 31, 2023. The Company estimates that its current cash and cash equivalents, which also include proceeds from its recent $21.0 million stock offering with ThinkEquity, will enable it to fund its operations into the fourth quarter of 2025. The Company had 14.1 million shares of common stock outstanding as of December 31, 2024 and 19.5 million shares of common stock outstanding after the offering with ThinkEquity. About Annovis Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested 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 StatementsThis 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 DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis [email protected] (Tables to follow)

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook