MALVERN, Pa., April 29, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced the appointment Hui Liu as Director of Biostatistics. "Bringing Ms. Liu on board at this critical stage, as our pivotal Phase 3 AD trial advances, reinforces our commitment to scientific excellence," said Cheng F ...

MALVERN, Pa., March 27, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that on March 26, 2025, it received notice (the “Notice”) from the New York Stock Exchange (NYSE) that it is no longer in compliance with the NYSE continued listing standards set forth in Section 802.01B of the N ...

MALVERN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE:ANVS) ("Annovis"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced its participation in the AD/PD™ 2025 taking place April 1-5 in Vienna. "We are at a pivotal moment in our company's journey as we have entered the late clinical stages for both Alzheimer's and Parkinson's. It is incredibly rewardin ...

MALVERN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced its participation in the AD/PD™ 2025 taking place April 1-5 in Vienna. "We are at a pivotal moment in our company’s journey as we have entered the late clinical stages for both Alzheimer’s and Parkinson’s. It is incredibly rewardi ...

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].

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].

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]

MALVERN, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE:ANVS) ("Annovis"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), will participate at the 13th Alzheimer's & Parkinson's Drug Development Summit happening on March 18-20 in Boston, MA. "This meeting represents an important opportunity to advance our understanding of the next-generation treatment for neurodegener ...

MALVERN, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), will participate at the 13th Alzheimer’s & Parkinson’s Drug Development Summit happening on March 18-20 in Boston, MA. "This meeting represents an important opportunity to advance our understanding of the next-generation treatment for neurodegene ...

MALVERN, Pa., Feb. 19, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio, Inc. (NYSE:ANVS)  ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), will host a live webcast where CEO Maria Maccecchini, Ph.D., will answer questions from patients, caregivers, and families about the Company's clinical trials and future plans. Webcast Details Event: Annovis Patients' Forum: Your Que ...