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]

Core Insights - Annovis Bio, Inc. has fully activated all 84 clinical sites for its pivotal Phase 3 study in early Alzheimer's disease (AD), with patient enrollment and treatment underway [1][2] - The first group of participants has reached the 6-month treatment milestone, keeping the study on track for data readout in the second half of 2026 [1][2] - The Phase 3 trial aims to enroll a total of 760 patients with early AD and biomarker-confirmed amyloid pathology, featuring a dual design for evaluating symptomatic efficacy and potential disease-modifying response [2] Enrollment and Progress - The trial is currently 25% complete, demonstrating strong execution in patient enrollment and progression through the protocol [2][3] - The dedication of the team, site partners, and patient engagement has contributed to the momentum of the trial [3] Company Overview - Annovis is headquartered in Malvern, Pennsylvania, focusing on innovative therapies for neurodegenerative diseases such as AD and Parkinson's disease (PD) [4] - The company is committed to improving patient outcomes and quality of life through its drug development efforts [4]

Core Viewpoint - Annovis Bio, Inc. has announced a registered direct offering of 1,670,732 shares of its common stock at a price of $2.05 per share, aiming to raise approximately $3.4 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering price of $2.05 per share reflects the closing price on October 24, 2025 [1]. - The total gross proceeds from the offering are expected to be around $3.4 million before deducting fees and expenses [2]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. Group 2: Company Background - Annovis Bio is focused on developing therapies for neurodegenerative diseases, including Alzheimer's disease (AD) and Parkinson's disease (PD) [5]. - The company is headquartered in Malvern, Pennsylvania, and is committed to improving patient outcomes and quality of life through innovative therapies [5]. Group 3: Regulatory Information - The securities are being offered under a "shelf" registration statement previously filed with the SEC, which became effective on February 12, 2024 [3]. - A prospectus supplement related to the offering will be filed with the SEC and will be available on their website [3].

Core Viewpoint - Annovis Bio, Inc. has successfully closed a registered direct offering, raising approximately $6 million to support its operations in developing therapies for neurodegenerative diseases like Alzheimer's and Parkinson's disease [1][2]. Group 1: Offering Details - The company offered 4,000,000 shares of common stock at a price of $1.50 per share [1]. - H.C. Wainwright & Co. served as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering were around $6 million, which will be used for working capital and general corporate purposes [2]. Group 2: Regulatory Information - The securities were sold under a "shelf" registration statement on Form S-3, which was filed with the SEC on February 1, 2024, and declared effective on February 12, 2024 [3]. - A prospectus supplement related to the offering was filed with the SEC and is available on their website [3]. Group 3: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on innovative therapies for neurodegenerative diseases [5]. - The company aims to improve patient outcomes and quality of life through its research and development efforts [5].

Core Viewpoint - Annovis Bio, Inc. has announced a registered direct offering to sell 4,000,000 shares of its common stock at a price of $1.50 per share, aiming to raise approximately $6 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering is expected to close around October 13, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be about $6 million before deducting fees and expenses [2]. Group 2: Regulatory Information - The securities are being offered under a "shelf" registration statement on Form S-3, which was filed with the SEC on February 1, 2024, and declared effective on February 12, 2024 [3]. - A prospectus supplement and base prospectus related to the offering will be filed with the SEC and made available on their website [3]. Group 3: Company Overview - Annovis Bio is focused on developing therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease, with a commitment to improving patient outcomes [5].

Core Insights - Annovis Bio, Inc. announced new results indicating that its drug candidate, buntanetap, can reduce inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond just symptomatic relief [1][2]. Group 1: Clinical Study Results - The Phase 2/3 study analysis showed that buntanetap effectively targets key biomarkers of neuroinflammation and neurodegeneration, leading to reductions in inflammatory markers such as IL-5, IL-6, S100A12, IFN-γ, and IGF1R compared to placebo [2]. - Buntanetap also decreased levels of neurofilament light chain (NFL), a marker of neuronal damage, indicating improved cellular integrity and neuronal health, particularly in patients with positive pTau217 plasma levels [2][3]. Group 2: Mechanism and Therapeutic Potential - The drug's ability to target multiple neurotoxic proteins simultaneously is highlighted as a significant advantage, potentially interrupting the toxic cascade associated with Alzheimer's disease [3]. - Previous clinical benefits were noted in mild Alzheimer's patients, who experienced significant cognitive improvements, reinforcing the potential of buntanetap as a disease-modifying therapy [3]. Group 3: Ongoing Research and Future Outlook - Buntanetap is currently undergoing a pivotal Phase 3 trial in early Alzheimer's disease, with a 6-month readout focused on symptomatic improvement and an 18-month readout aimed at assessing disease modification [3][4]. - The full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, which is expected to provide further insights into the drug's efficacy [4].

Core Viewpoint - Annovis Bio, Inc. has appointed Mark Guerin as Chief Financial Officer to guide the company through a critical phase as its drug candidate, buntanetap, shows promise in late-stage clinical development for neurodegenerative diseases [1][5] Company Overview - Annovis Bio is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease [1][6] - The company is headquartered in Malvern, Pennsylvania, and is dedicated to improving patient outcomes and quality of life through innovative therapies [6] Leadership Experience - Mark Guerin has extensive experience in financial operations within biopharma companies, having served as CFO at Onconova Therapeutics (now Traws Pharma) and facilitated critical financing transactions [2][3] - Prior to Onconova, Guerin held senior finance roles, including Vice President of Finance and CFO at Cardiokine, Inc., overseeing its New Drug Application filing and sale [3][4] Financial Strategy - During his tenure at Onconova, Guerin was instrumental in completing several financing transactions, including a $20 million financing in December 2024 [2] - His experience includes managing financial reporting, forecasting, and internal controls, which will be beneficial for Annovis as it advances its clinical programs [2][5]

Core Insights - Annovis Bio, Inc. has published a new article in the peer-reviewed journal Biomolecules detailing the pharmacokinetic profile of a new crystal form of buntanetap, which is being developed for neurodegenerative diseases like Alzheimer's and Parkinson's [1][2]. Group 1: New Crystal Form of Buntanetap - The newly identified dihydrate crystal form of buntanetap offers greater stability compared to the original anhydrous form, which has been used in all previous studies [2]. - The publication confirms that the new crystal form maintains the pharmacokinetic profile and metabolism essential for the drug's therapeutic efficacy [2][4]. Group 2: Clinical Trials and Intellectual Property - The new crystal form of buntanetap is currently being utilized in a pivotal Phase 3 clinical trial (NCT06709014) for early Alzheimer's disease, with key readouts expected in Fall 2026 and Fall 2027 [4]. - This new form extends the intellectual property protection of the lead compound into the 2040s, covering its mechanism of action, therapeutic use, and potential combinations with other drugs [4]. Group 3: Company Commitment and Communication - The company emphasizes its commitment to rigorous analysis of buntanetap to ensure beneficial outcomes for patients [4]. - Annovis Bio is dedicated to developing innovative therapies aimed at improving patient outcomes and quality of life in neurodegenerative diseases [6].

Summary of Innovus Bio Conference Call Company Overview - **Company**: Innovus Bio - **Drug**: Buntanetab - **Indication**: Alzheimer's Disease - **Current Phase**: Phase three pivotal study Key Points and Arguments Alzheimer's Drug Development Landscape - Historical context: Several drugs developed around 2000 improved cognition short-term, followed by a 20-year period with no approvals [2][3] - Recent approvals focus on slowing cognitive decline rather than improving cognition [3] - Over 180 ongoing Alzheimer's studies indicate a surge in drug development [3] Buntanetab's Unique Mechanism - Buntanetab is positioned as a disease-modifying drug that improves cognition short-term while protecting nerve cells long-term [4][7] - It is orally available, easy to administer, and has no side effects [8] - Targets four toxic proteins associated with Alzheimer's: plaque, tau, alpha-synuclein, and TDP-43 [11][12] - Acts on mRNA to inhibit the synthesis of these proteins, differentiating it from existing drugs [12] Efficacy in Animal Studies - Demonstrated both symptomatic and disease-modifying efficacy in eight different animal models [23] - Protects nerve cells from dying in traumatic brain injury and glaucoma models [21][22] Human Clinical Trials - Conducted 12 studies in humans, including small studies in healthy volunteers and early Alzheimer patients [23] - Small studies showed significant improvement in cognition compared to placebo, with a 3.5 to 4.5 ADS cog points improvement [25] - A larger study with 350 patients did not meet primary endpoints but showed a significant dose-response curve in early moderate patients [26][27] - Ongoing large study with 760 early Alzheimer patients lasting 18 months, with dual endpoints for symptomatic and disease modification [36] Comparison with Existing Treatments - Buntanetab shows a 3 to 4 point improvement in ADS cog at three months, compared to existing drugs like Aricept and Kisumbla, which show limited efficacy over time [31][34] - The drug works effectively across various demographics, including APOE4 positive and negative patients [27][28] Future Outlook - Anticipated NDA filings: Six-month data by the end of next year and 18-month data by 2027 [36] - The study design includes both symptomatic and disease-modifying endpoints, with a focus on volumetric MRI and biomarkers [37] Intellectual Property - Innovus Bio has 13 patent families extending patent life until 2044, including a novel crystal form developed last year [38] Additional Important Information - The drug's mechanism improves axonal transport, which is crucial for cognitive function [15][20] - Inflammation reduction is achieved indirectly by keeping nerve cells healthy, thus preventing immune system attacks [19][20] - The drug's efficacy is supported by biomarker improvements in neurofilament light and inflammatory factors [30]

Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] Group 1: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania and is dedicated to addressing neurodegeneration in diseases like Alzheimer's and Parkinson's [4] - The company aims to develop innovative therapies that improve patient outcomes and quality of life [4] Group 2: Upcoming Events - CEO Maria Maccecchini, Ph.D., will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, at the Lotte New York Palace Hotel [1] - Interested parties can schedule one-on-one meetings with Dr. Maccecchini through the conference portal [3]