Annovis Bio(ANVS)

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Annovis to Attend AD/PD™ 2025 with Extensive Scientific Program
Globenewswire· 2025-03-25 12:00
Core Insights - Annovis Bio Inc. is advancing in late-stage clinical trials for Alzheimer's disease (AD) and Parkinson's disease (PD), showcasing the efficacy and safety of its drug [2][3] - The company will present data from its Phase 3 PD study and Phase 2/3 AD study at the AD/PD™ 2025 conference in Vienna [1][2] Company Overview - Annovis Bio is focused on developing transformative therapies for neurodegenerative diseases, particularly AD and PD, with a commitment to improving patient outcomes and quality of life [4] - The company is headquartered in Malvern, Pennsylvania, and actively engages with investors through updates and alerts [5][8] Conference Participation - Annovis will deliver two presentations: one on the cognitive and motor function improvements in early Parkinson's patients and another on the benefits of its drug for APOE4 carriers in Alzheimer's patients [3][7] - The company will also participate in a forum discussing novel approaches to accelerate the development of biomarkers and therapies related to PD and other neurological disorders [3]
Annovis to Attend AD/PD™ 2025 with Extensive Scientific Program
Newsfilter· 2025-03-25 12:00
Core Insights - Annovis Bio Inc. is participating in the AD/PD™ 2025 conference from April 1-5 in Vienna, focusing on transformative therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][2]. Company Overview - Annovis Bio is a late-stage clinical drug platform company headquartered in Malvern, Pennsylvania, dedicated to developing innovative therapies aimed at improving patient outcomes in neurodegenerative diseases [4]. Clinical Developments - The company is in late clinical stages for both Alzheimer's and Parkinson's diseases, with upcoming presentations at the conference showcasing data from Phase 3 PD and Phase 2/3 AD studies [2]. - The presentations will cover the cognitive response in early Parkinson's patients and the benefits of the drug buntanetap for APOE4 carriers in Alzheimer's patients [2][3]. Conference Participation - Annovis will present two key studies and participate in a forum discussion on novel approaches to accelerate the development of biomarkers and therapies related to Parkinson's disease and other neurological disorders [3]. - Specific presentation details include: - "BUNTANETAP IMPROVES EARLY PARKINSON'S PATIENTS' COGNITION AND MOTOR FUNCTIONS IN A PHASE 3 STUDY" [3]. - "APOE4 AND BUNTANETAP IN PHASE II/III ALZHEIMER'S PATIENTS" [3]. Leadership Engagement - Maria Maccecchini, Ph.D., Founder and CEO, will present on April 1 and April 4, while Cheng Fang, Ph.D., SVP of Research and Development, will present on April 2 [7].
Annovis Bio(ANVS) - 2024 Q4 - Annual Report
2025-03-21 21:15
Financial Performance - The company reported a net loss of $24.6 million for the year ended December 31, 2024, a decrease of $31.6 million compared to a net loss of $56.2 million in 2023[424]. - The company has accumulated a deficit of $134.8 million as of December 31, 2024, and expects to incur losses for the foreseeable future[413]. - Interest income decreased by $0.3 million for the year ended December 31, 2024, attributed to lower cash and cash equivalent balances[427]. - Financing costs were $1.9 million for the year ended December 31, 2024, compared to no financing costs in 2023, due to issuance costs and changes in derivative fair value[428]. - The change in fair value of warrants resulted in a gain of $3.6 million for the year ended December 31, 2024, compared to a loss of $11.8 million in 2023[429]. - As of December 31, 2024, the company's cash and cash equivalents totaled $10.6 million, indicating ongoing liquidity challenges[431]. - Cash used in operating activities was $21.9 million for the year ended December 31, 2024, a decrease from $40.0 million in 2023, reflecting reduced clinical activity[448]. - Cash provided by financing activities was $26.7 million for the year ended December 31, 2024, primarily from common stock and warrant issuances[450]. - The company expects to incur significant operating losses for the foreseeable future as it ramps up clinical development programs[441]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory requirements, with substantial doubt regarding the ability to continue as a going concern within one year[440]. Research and Development - Research and development expenses decreased to $20.0 million in 2024 from $38.8 million in 2023, reflecting a reduction of $18.8 million[424]. - 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 existing cognitive issues[407]. - The Phase 2/3 AD Study was completed on February 13, 2024, with topline efficacy data announced on April 29, 2024, indicating dose-dependent improvements in cognition[408]. - The company expects elevated research and development expenses in 2025 and beyond due to ongoing clinical trials and preparations for potential NDA filings[418]. - Research and development expenses decreased by $18.8 million for the year ended December 31, 2024, compared to 2023, primarily due to the completion of major clinical trials[425]. - Research and development expenses for the year ended December 31, 2024, were $3.8 million, compared to $4.6 million for 2023, indicating a decrease of approximately 17.4%[461]. Administrative Expenses - General and administrative expenses increased slightly to $6.7 million in 2024 from $6.2 million in 2023, an increase of $0.5 million[424]. - General and administrative expenses increased by $0.5 million for the year ended December 31, 2024, mainly due to warrant exercise commissions[426]. Stock-Based Compensation - As of December 31, 2024, the company had $2.4 million of unrecognized stock-based compensation expense, which will be recognized over a remaining weighted-average period of 1.0 years[461]. - Stock-based compensation expense was recorded as $3.8 million for 2024, reflecting the company's ongoing investment in employee incentives[461]. - Stock-based compensation awards are recognized in the statements of operations based on their grant date fair values, with forfeitures recognized as they occur[457]. Accounting and Reporting - The company adopted ASU 2023-07 for segment reporting, effective January 1, 2024, which requires public entities to disclose significant expenses and other segment items annually[463]. - The company has not determined the impact of ASU 2023-09 on its financial statement disclosures but does not expect material impacts[465]. - The company has irrevocably elected not to take advantage of the JOBS Act exemption, thus adhering to the same new or revised accounting standards as other public companies[467]. - The fair value of Common Stock Warrant Liabilities is determined using a Black-Scholes option-pricing model, which requires considerable judgment and may lead to significant differences in reported values[462]. - The assumptions used in the Black-Scholes option-pricing model include expected term, expected volatility, risk-free interest rate, and expected dividends, which are inherently subjective[459].
Annovis Bio(ANVS) - 2024 Q4 - Annual Results
2025-03-21 21:10
Clinical Trials and Research Advancements - In 2024, Annovis advanced the buntanetap program, completing two clinical trials: Phase 2/3 for Alzheimer's disease (AD) and Phase 3 for Parkinson's disease (PD) with promising results[2]. - Annovis launched a pivotal Phase 3 AD study in February 2025, with symptomatic data expected in mid-2026 and disease-modifying data in mid-2027[5]. - The company appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist in October 2024 to oversee clinical trials[5]. Financial Performance - Annovis reported a basic and diluted net loss per share of $0.43 for Q4 2024, significantly improved from a loss of $2.24 per share in Q4 2023[5]. - The company reported a net loss of $5.9 million for Q4 2024, a significant reduction from a loss of $22.2 million in Q4 2023[13]. - For the full year 2024, research and development expenses totaled $20.0 million, down 48.5% from $38.8 million in 2023[5]. - Research and development expenses for Q4 2024 were $5.0 million, a decrease of 43.3% from $8.9 million in Q4 2023[5]. Assets and Equity - The company had cash and cash equivalents of $10.6 million as of December 31, 2024, an increase from $5.8 million as of December 31, 2023[5]. - Annovis' total assets increased to $13.9 million as of December 31, 2024, compared to $10.2 million in 2023[11]. - Annovis' total stockholders' equity improved to $9.3 million as of December 31, 2024, compared to a deficit of $7.8 million in 2023[11].
Annovis Provides Corporate Updates and Reports Fourth Quarter and Fiscal Year 2024 Financial Results
Globenewswire· 2025-03-21 21:05
Core Insights - Annovis Bio Inc. is advancing its late-stage clinical drug platform focused on neurodegenerative diseases, specifically Alzheimer's disease (AD) and Parkinson's disease (PD) [1][2] - The company has made significant progress with its buntanetap program, completing two clinical trials that showed promising results in improving cognition and motor function [2][3] - Annovis has received FDA clearance to proceed with a pivotal Phase 3 trial for early AD, which commenced in early 2025 [2][6] Clinical Progress - In 2024, Annovis completed Phase 2/3 AD and Phase 3 PD clinical trials, demonstrating symptomatic improvement in early AD patients [2][6] - The pivotal Phase 3 AD study includes a 6-month data readout for symptomatic effects, with results expected in mid-2026, followed by a 12-month assessment for disease-modifying response anticipated in mid-2027 [6] - Annovis has expanded its team and patent portfolio, and participated in key scientific conferences to present findings and discuss its treatment mechanisms [2][6] Financial Results - For Q4 2024, research and development expenses were $5.0 million, down from $8.9 million in Q4 2023, while general and administrative expenses increased slightly to $1.7 million from $1.5 million [6] - The net loss per share for Q4 2024 was $0.43, significantly improved from a loss of $2.24 per share in Q4 2023 [6][15] - For the full year 2024, research and development expenses totaled $20.0 million, down from $38.8 million in 2023, with a net loss per share of $2.02 compared to $6.23 in 2023 [6][15] Cash Position - As of December 31, 2024, Annovis had cash and cash equivalents of $10.6 million, an increase from $5.8 million a year earlier [7] - The company expects its current cash position, bolstered by a recent $21.0 million stock offering, to fund operations into Q4 2025 [7]
Annovis Joins Experts at Drug Development Summit to Redefine Parkinson's Treatment
GlobeNewswire News Room· 2025-03-11 12:00
Core Insights - Annovis Bio Inc. is participating in the 13th Alzheimer's & Parkinson's Drug Development Summit from March 18-20 in Boston, focusing on transformative therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][2] Company Overview - Annovis Bio is a late-stage clinical drug platform company headquartered in Malvern, Pennsylvania, dedicated to developing innovative therapies aimed at improving patient outcomes in neurodegenerative diseases [3] Event Participation - The company will present findings from its Phase III clinical trials of Buntanetap and discuss a holistic approach to treating neurodegenerative diseases, emphasizing the need to address multiple neurotoxic proteins rather than focusing on a single target [2] - Annovis will participate in a panel discussion on March 19, exploring opportunities in targeting alpha-synuclein and the future of Parkinson's drug development [2] Research Focus - The summit aims to provide comprehensive coverage of the drug development process, from early discovery to late-stage development, with a focus on novel therapeutic targets for neurodegenerative diseases [2]
Annovis Joins Experts at Drug Development Summit to Redefine Parkinson's Treatment
Newsfilter· 2025-03-11 12:00
Core Insights - Annovis Bio Inc. is participating in the 13th Alzheimer's & Parkinson's Drug Development Summit to discuss advancements in treatments for neurodegenerative diseases [1][2] - The company emphasizes the need for a holistic approach to treatment, addressing multiple neurotoxic proteins rather than focusing on a single target [2] Company Overview - Annovis Bio is a late-stage clinical drug platform company based in Malvern, Pennsylvania, dedicated to developing therapies for Alzheimer's disease (AD) and Parkinson's disease (PD) [1][3] - The company aims to improve patient outcomes and quality of life through innovative therapies [3] Event Participation - Annovis will present data from Phase III clinical trials of its drug Buntanetap and participate in a panel discussion on March 19, focusing on new therapeutic approaches for Parkinson's disease [2] - The summit is recognized as a comprehensive industry-focused meeting that covers the entire spectrum of neurodegenerative disease research and development [2]
Annovis to Host Patients' Live Forum on February 27, 2025
Newsfilter· 2025-02-19 13:30
Core Viewpoint - Annovis Bio, Inc. is hosting a live webcast to provide updates on its clinical trials for neurodegenerative diseases, specifically Alzheimer's disease and Parkinson's disease, while addressing questions from patients and caregivers [1][2][3]. Group 1: Webcast Details - The webcast will feature CEO Maria Maccecchini providing updates on the ongoing Phase 3 trial for Alzheimer's disease, as well as plans for the Phase 3 trial for Parkinson's disease and Open Label Extension studies [2]. - A short presentation will highlight recent achievements, followed by a Q&A session where attendees can submit questions in advance [2]. Group 2: Company Mission and Approach - Annovis Bio is focused on addressing neurodegeneration in diseases such as Alzheimer's and Parkinson's, utilizing an innovative approach that targets multiple neurotoxic proteins to restore brain function and improve patients' quality of life [4]. - The company emphasizes transparency and patient-centric communication, aiming to address questions from patients, families, and caregivers [3]. Group 3: Investor Engagement - Investors and shareholders are encouraged to sign up for press releases and industry updates through the company's email alerts [5]. - The updated investor website offers comprehensive access to company news, financial reports, and other key information [5].
Annovis to Host Patients' Live Forum on February 27, 2025
GlobeNewswire News Room· 2025-02-19 13:30
Core Viewpoint - Annovis Bio, Inc. is hosting a live webcast to provide updates on its clinical trials for neurodegenerative diseases, specifically Alzheimer's disease and Parkinson's disease, while engaging with patients, caregivers, and families [1][2][3] Group 1: Webcast Details - The webcast will feature CEO Dr. Maria Maccecchini discussing the ongoing Phase 3 trial for Alzheimer's disease, plans for the Phase 3 trial for Parkinson's disease, and patient communication strategies [2] - A short presentation will highlight recent achievements, followed by a Q&A session where attendees can submit questions in advance [2] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, focusing on innovative therapies for neurodegenerative diseases by targeting multiple neurotoxic proteins to restore brain function [4] - The company emphasizes its commitment to transparency and patient engagement, aiming to address questions from current and prospective patients [3] Group 3: Investor Engagement - Investors and shareholders are encouraged to sign up for press releases and industry updates through the company's email alerts [5] - The updated investor website offers comprehensive access to company news, financial reports, and other key information [5]
Annovis to Present at Oppenheimer's 35th Annual Healthcare Life Sciences Conference
Globenewswire· 2025-02-07 13:00
Core Insights - Annovis Bio Inc. is a late-stage clinical drug platform company focused on developing therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] - The CEO, Dr. Maria Maccecchini, will present at Oppenheimer's 35th Annual Healthcare Life Sciences Conference, discussing the company's advancements and the pivotal Phase 3 trial for its drug, buntanetap [1][2] 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 enhance patient outcomes and quality of life [4] Conference Details - The Oppenheimer's Annual Healthcare Life Sciences Conference is a significant event that gathers leading companies and investors in the healthcare and life sciences sectors [3] - The conference features presentations from industry executives, offering insights into current trends, innovations, and investment opportunities [3]