Summary of Annovis Bio (ANVS) Update / Briefing June 24, 2025 Company Overview - **Company**: Annovis Bio (ANVS) - **Focus**: Development of treatments for neurodegenerative diseases, specifically Alzheimer's and Parkinson's diseases Key Points and Arguments Alzheimer's Disease Program - Annovis Bio is conducting a pivotal Phase 3 trial for Alzheimer's, with expectations to file a New Drug Application (NDA) for both symptomatic and disease-modifying treatments [3][4] - The company has completed a large study with 350 patients and is currently conducting a study with 760 early Alzheimer's patients [6][20] - Initial studies showed a 3.5-point improvement in cognition over placebo, indicating potential efficacy [9][28] - The company emphasizes the safety of its drug, pontanetab, particularly in APOE4 carriers, where no significant side effects were observed [13] Parkinson's Disease Program - A large study in Parkinson's has been completed, and an open-label study is planned for patients with deep brain stimulation [4][30] - The drug has shown cognitive improvement in Parkinson's patients, particularly those with cognitive impairment [14][15] - The company is preparing to submit protocols for pivotal studies in Parkinson's disease dementia and dementia with Lewy bodies [30][34] Clinical Trials and Data - The company has treated over 800 patients across various studies, focusing on safety and efficacy [5] - The screening process for the current Alzheimer's study has a 38% failure rate, primarily due to strict inclusion criteria [23][54] - The company aims to recruit 1,500 patients and randomize 760 for the Alzheimer's study, with a target of completing enrollment by the end of the year [22][44] Regulatory and Market Considerations - The FDA has been supportive, with potential for fast-tracking the approval process for drugs addressing significant unmet needs [39] - If the data from the ongoing studies are positive, the company anticipates filing for NDA by fall 2027 for symptomatic treatment and fall 2028 for disease modification [39][86] - The company is actively seeking funding to support ongoing and future studies, with a current focus on raising $70 million for Parkinson's studies [73][92] Other Important Content - The company is exploring the use of biomarkers and volumetric MRI to assess disease modification and cognitive improvement [18][50] - There is a discussion about the impact of FDA leadership changes on drug development for neurodegenerative diseases, with a focus on ensuring fair evaluation processes for both biologics and traditional drugs [56] - The company is open to public support and lobbying for funding to enhance research and development efforts [120][126] This summary encapsulates the key points from the Annovis Bio briefing, highlighting the company's focus on Alzheimer's and Parkinson's disease treatments, ongoing clinical trials, regulatory strategies, and funding challenges.

Core Viewpoint - Annovis Bio, Inc. has received acceptance from the NYSE for its plan to regain compliance with listing standards related to market capitalization and stockholders' equity [1][2]. Group 1: Compliance Plan - The NYSE has granted Annovis an 18-month period to regain compliance, starting from the notice of noncompliance received on March 26, 2025 [2]. - Annovis is required to provide quarterly updates to the NYSE regarding its progress towards the goals outlined in the compliance plan [2]. Group 2: Listing Status - The company expects its stock to remain listed on the NYSE during the compliance period, contingent upon adherence to the plan and other listing standards [3]. - The acceptance notification does not impact the company's business operations or reporting obligations with the U.S. Securities and Exchange Commission [3]. Group 3: Company Overview - Annovis is focused on developing transformative therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease [1][5]. - The company aims to improve patient outcomes and quality of life through innovative therapies [5].

Core Viewpoint - Annovis Bio, Inc. (ANVS) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on a company's changing earnings picture, specifically the consensus of EPS estimates from sell-side analysts [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, leading to buying or selling actions that affect stock prices [4]. Annovis Bio's Earnings Outlook - The Zacks Consensus Estimate for Annovis Bio has increased by 9.8% over the past three months, indicating a positive trend in earnings estimates [8]. - For the fiscal year ending December 2025, Annovis Bio is expected to earn -$1.52 per share, which remains unchanged from the previous year [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks generating an average annual return of +25% since 1988 [7]. - The upgrade of Annovis Bio to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Points - Annovis Bio, Inc. is a clinical-stage drug platform company focused on developing therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] - The company will host a live webcast featuring updates on its pivotal Phase 3 trial in early Alzheimer's disease and feedback from the FDA regarding its Parkinson's disease program [2] - The webcast is open to various stakeholders including shareholders, patients, and investigators, allowing for direct engagement with the CEO [3] Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and aims to address neurodegeneration by targeting multiple neurotoxic proteins to restore brain function and improve patient quality of life [4] - The company encourages interested investors and shareholders to sign up for press releases and industry updates through its investor website [5]

Financial Performance - Annovis reported cash and cash equivalents of $22.2 million as of March 31, 2025, up from $10.6 million a year earlier, representing a 109.4% increase[9] - The net loss for Q1 2025 was $5.5 million, compared to a net loss of $1.1 million in Q1 2024, indicating a significant increase in losses[9] - The basic and diluted net loss per share for Q1 2025 was $0.32, compared to $0.10 (basic) and $0.72 (diluted) in Q1 2024[13] - The total operating expenses for Q1 2025 were $6.3 million, down from $7.8 million in Q1 2024, reflecting a 19.5% reduction[13] Research and Development - Research and development expenses for Q1 2025 were $5.0 million, a decrease of 23.1% compared to $6.5 million in Q1 2024[9] - Annovis is conducting a pivotal Phase 3 clinical trial for early Alzheimer's disease, aiming to enroll approximately 760 participants[2] - Annovis participated in multiple key scientific conferences in early 2025, presenting findings from its Phase 3 PD trial and data on buntanetap[4] Intellectual Property - The company received a U.S. patent in January 2025 for methods related to the treatment and prevention of acute brain and nerve injuries using buntanetap[4] Administrative Expenses - General and administrative expenses remained stable at $1.3 million for both Q1 2025 and Q1 2024[9] - The company had 19.5 million shares of common stock outstanding as of March 31, 2025, an increase from 14.1 million shares a year prior[9]

Financial Performance - The company reported a net loss of $5.5 million for the three months ended March 31, 2025, compared to a net loss of $1.1 million for the same period in 2024, representing an increase in loss of $4.5 million[113]. - Total operating expenses for the three months ended March 31, 2025, were $6.3 million, a decrease of $1.5 million from $7.8 million in the same period of 2024[113]. - Cash used in operating activities was $8.1 million in Q1 2025, an increase of $1.1 million from $7.0 million in Q1 2024, primarily due to higher clinical trial expenses[126]. - The company has an accumulated deficit of $140.4 million as of March 31, 2025, and expects to incur losses for the foreseeable future[110]. - The company has not generated any revenue from product sales since inception and does not anticipate doing so in the foreseeable future[119]. Research and Development - Research and development expenses decreased by $1.5 million to $5.0 million for the three months ended March 31, 2025, down from $6.5 million in the same period of 2024[114]. - The pivotal Phase 3 AD trial is set to confirm symptomatic efficacy over a 6-month treatment period, followed by an additional 12 months to assess potential disease-modifying efficacy[105]. - 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[102]. - The company is developing buntanetap, a drug designed to inhibit multiple neurotoxic proteins associated with neurodegeneration, with the potential to be the first drug to improve cognition in Alzheimer's disease and motor function in Parkinson's disease[107]. - The FDA has aligned with the company on a development path for buntanetap towards filing New Drug Applications for both short-term and long-term efficacy[104]. Capital and Financing - The company plans to raise additional capital to fund operations and clinical trials, as it does not have sufficient capital to meet obligations for the next 12 months[111]. - The February 2025 public offering generated gross proceeds of $21.0 million, with net proceeds of $19.3 million from the sale of 5.3 million units priced at $4.00 each[120]. - During Q1 2025, the company sold 0.1 million shares under an equity distribution agreement, raising gross proceeds of $0.5 million[122]. - Cash provided by financing activities was $19.8 million in Q1 2025, significantly higher than $4.4 million in Q1 2024, mainly from the ThinkEquity offering and ATM facility[128]. - Interest income increased to $188,000 for the three months ended March 31, 2025, compared to $44,000 in the same period of 2024, reflecting a $144,000 increase[113]. Cash Position - As of March 31, 2025, the company's cash and cash equivalents totaled $22.2 million, insufficient to fund operations for the next twelve months[119]. - Interest income for Q1 2025 was $0.2 million, up from $0.0 million in Q1 2024, attributed to increased cash balances from a public offering[117]. - Change in fair value of warrants showed a gain of $0.5 million in Q1 2025, down from a gain of $6.7 million in Q1 2024, due to fewer outstanding warrants and stock price changes[118]. - The company expects elevated operating cash burn in 2025 due to costs associated with completing a Phase 3 trial for Alzheimer's Disease[127]. Accounting Policies - There were no significant changes to critical accounting policies during the three-month period ended March 31, 2025[132].

Core Viewpoint - Annovis Bio Inc. is advancing its pivotal Phase 3 clinical trial for Alzheimer's disease, with a focus on the drug buntanetap, while also reporting significant financial updates for the first quarter of 2025 [1][2][3]. Corporate Updates - The pivotal Phase 3 clinical trial for early Alzheimer's disease began on February 5, 2025, aiming to enroll approximately 760 participants to evaluate the drug's symptomatic benefits and potential disease-modifying effects [2]. - Annovis management has actively participated in several key scientific conferences, presenting findings related to neurodegenerative diseases and engaging with the healthcare community [8]. Financial Results - As of March 31, 2025, Annovis reported cash and cash equivalents of $22.2 million, an increase from $10.6 million a year earlier [8]. - Research and development expenses for Q1 2025 were $5.0 million, down from $6.5 million in Q1 2024, while general and administrative expenses remained stable at $1.3 million [8]. - The company reported a net loss of $5.5 million for Q1 2025, with a basic and diluted net loss per share of $0.32, compared to a net loss of $1.1 million and a diluted net loss per share of $0.72 in the same period last year [8][13].

Core Insights - Annovis Bio Inc. has appointed Hui Liu as Director of Biostatistics to enhance the integrity of its clinical trials as it advances its pivotal Phase 3 trial for Alzheimer's disease [2][3] Company Overview - Annovis Bio Inc. is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative disorders, including Alzheimer's disease and Parkinson's disease [1][3] - The company is headquartered in Malvern, Pennsylvania, and is dedicated to improving patient outcomes and quality of life through innovative therapies [3] Appointment of Hui Liu - Hui Liu brings over 19 years of experience in clinical trial design, analysis, and reporting across various therapeutic areas, with expertise in statistical methodology [2] - Liu's role will involve authoring statistical analysis plans, developing programming specifications, and interpreting complex data to support regulatory submissions [2] - The appointment is seen as a reinforcement of the company's commitment to scientific excellence and robust regulatory submissions [2]

Core Viewpoint - Annovis Bio, Inc. has received a notice from the NYSE regarding non-compliance with continued listing standards due to its market capitalization and stockholders' equity falling below the required thresholds [1][2]. Company Financials - As of March 25, 2025, Annovis Bio's average market capitalization over a 30 trading-day period was approximately $37.9 million, which is below the $50 million requirement [2]. - The last reported stockholders' equity for the company as of December 31, 2024, was $9.3 million, also below the required $50 million [2]. Compliance Plan - The company plans to submit a compliance plan to the NYSE within 45 days of receiving the notice, detailing actions to regain compliance within 18 months [3]. - If the NYSE accepts the plan, the company's common stock will continue to be listed and traded, but will carry a ".BC" designation indicating non-compliance [4]. Impact on Operations - The notice does not affect the company's business operations or its reporting obligations with the SEC, nor does it trigger any default under material debt agreements [2]. - The common stock will continue to trade under the symbol "ANVS" during the compliance period, subject to adherence to the plan [4].

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]