[Report Overview](index=1&type=section&id=Report%20Overview) Annovis Bio, Inc. (NYSE: ANVS) released its Q2 2025 financial results and corporate updates on August 12, 2025, detailing progress in neurodegenerative disease treatments [Introduction](index=1&type=section&id=Introduction) Annovis Bio, Inc. (NYSE: ANVS), a late-stage clinical drug platform company, released its Q2 2025 financial results and corporate updates on August 12, 2025 - Annovis Bio, Inc. (NYSE: ANVS) is a late-stage clinical drug platform company focused on treating neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD)[1](index=1&type=chunk) - The company provided its latest corporate updates and Q2 2025 financial results on August 12, 2025[1](index=1&type=chunk) [CEO Statement](index=1&type=section&id=CEO%20Statement) Dr. Maria Maccecchini highlighted patient enrollment for the early AD pivotal Phase III trial, new scientific findings at AAIC 2025, and strengthened global IP protection for crystalline buntanetap - The quarter's focus was on advancing patient enrollment for the early AD pivotal Phase III clinical trial, with **76 clinical sites secured in the US** and **over 400 patients screened**[2](index=2&type=chunk) - Latest scientific discoveries were presented at AAIC 2025[2](index=2&type=chunk) - Global intellectual property protection was strengthened by completing the transfer of all patent families to crystalline buntanetap[2](index=2&type=chunk) [Corporate Updates](index=1&type=section&id=Corporate%20Updates) Annovis made significant strides in clinical trials, patient enrollment, and intellectual property protection, alongside key scientific presentations and business communications [Clinical Highlights](index=1&type=section&id=Clinical%20highlights) Annovis's early AD pivotal Phase III study is rapidly progressing with patient enrollment, new biostatistics leadership, and scientific presentations at AAIC 2025 - The early AD pivotal Phase III study (NCT06709014) is progressing rapidly, with **76 US trial sites secured** and **46 actively recruiting patients**[4](index=4&type=chunk) - **38 patients** have received buntanetap or placebo, with nearly **200 more patients currently being screened**, and a screening failure rate consistent with the expected **50%**[4](index=4&type=chunk) - In April, Annovis hired Hui Liu as Director of Biostatistics[4](index=4&type=chunk) - In July, senior Annovis members attended AAIC 2025, presenting **four scientific posters** highlighting Alzheimer's disease Phase III study and buntanetap pharmacokinetics progress[4](index=4&type=chunk) [Business Highlights](index=1&type=section&id=Business%20highlights) Annovis hosted a Phase III trial update webinar and completed the transfer of all patent families to crystalline buntanetap, ensuring comprehensive global IP coverage - In June, Annovis hosted a webinar providing Phase III trial updates[4](index=4&type=chunk) - In August, Annovis announced the successful transfer of all patent families to crystalline buntanetap, achieving comprehensive global intellectual property coverage for both original and new forms of its drug candidate[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Annovis reported improved net loss per share in Q2 2025, increased cash, and reduced R&D and G&A expenses compared to the prior year [Summary of Financial Performance](index=2&type=section&id=Summary%20of%20Financial%20Performance) Annovis reported a basic and diluted net loss per share of $0.32 in Q2 2025, an improvement from $0.44 in the same period of 2024, with increased cash and reduced operating expenses | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :--------------- | | Cash and Cash Equivalents | $17.1 million | $10.6 million | | Metric | Q2 2025 | Q2 2024 | | :-------------------------------- | :------------- | :------------- | | Research and Development Expenses | $5.2 million | $5.8 million | | General and Administrative Expenses | $1.1 million | $2.0 million | | Basic and Diluted Net Loss Per Share | $0.32 | $0.44 | [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of June 30, 2025, Annovis's total assets increased to $21.45 million, driven by higher cash, while total liabilities decreased and stockholders' equity significantly rose | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :--------------- | | Cash and Cash Equivalents | $17,130,286 | $10,551,916 | | Prepaid Expenses and Other Current Assets | $4,324,285 | $3,373,717 | | **Total Assets** | **$21,454,571** | **$13,925,633** | | Accounts Payable | $974,311 | $2,305,974 | | Accrued Expenses | $1,830,813 | $1,575,013 | | Total Current Liabilities | $2,805,124 | $3,880,987 | | Warrant Liability | $319,000 | $737,000 | | **Total Liabilities** | **$3,124,124** | **$4,617,987** | | Common Stock Issued (shares) | 19,486,231 | 14,141,521 | | Additional Paid-in Capital | $164,935,088 | $144,155,694 | | Accumulated Deficit | $(146,606,589) | $(134,849,462) | | **Total Stockholders' Equity** | **$18,330,447** | **$9,307,646** | [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) Annovis's net loss for the three months ended June 30, 2025, was $6.22 million, an increase from $5.02 million in the prior year, primarily due to a significant reduction in other income | Operating Expenses (Three Months Ended June 30) | 2025 | 2024 | | :------------------------------------------ | :--------- | :--------- | | Research and Development Expenses | $5,161,921 | $5,785,217 | | General and Administrative Expenses | $1,109,532 | $1,977,421 | | **Total Operating Expenses** | **$6,271,453** | **$7,762,638** | | Loss from Operations | $(6,271,453) | $(7,762,638) | | Interest Income | $191,395 | $25,978 | | Change in Fair Value of Warrant Liability | $(140,000) | $4,062,308 | | **Net Loss** | **$(6,220,058)** | **$(5,020,412)** | | Basic Net Loss Per Share | $(0.32) | $(0.44) | | Diluted Net Loss Per Share | $(0.32) | $(0.44) | [About Annovis Bio, Inc.](index=2&type=section&id=About%20Annovis) Annovis Bio, Inc. is a clinical-stage pharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases [About Annovis Bio, Inc.](index=2&type=section&id=About%20Annovis%20Bio%2C%20Inc.) Annovis Bio, based in Malvern, PA, is dedicated to developing innovative therapies for neurodegenerative diseases like AD and PD to improve patient outcomes - Annovis is headquartered in Malvern, Pennsylvania[7](index=7&type=chunk) - The company is dedicated to addressing neurodegeneration in diseases such as AD and PD[7](index=7&type=chunk) - Annovis is committed to developing innovative therapies to improve patient outcomes and quality of life[7](index=7&type=chunk) [Additional Information](index=2&type=section&id=Additional%20Information) This section provides important disclosures regarding investor communications, forward-looking statements, and company contact details [Investor Alerts](index=2&type=section&id=Investor%20Alerts) Interested investors and shareholders are encouraged to register for email alerts via the company website for news releases and industry updates - Investors and shareholders can register for email alerts via the company website to receive news releases and industry updates[8](index=8&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements subject to SEC regulations, with actual results potentially differing due to risks outlined in company filings - This press release contains forward-looking statements subject to the Securities Act of 1933 and the Securities Exchange Act of 1934[9](index=9&type=chunk) - Actual results may differ due to various risks and uncertainties, which are detailed in the "Risk Factors" sections of the company's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC[9](index=9&type=chunk) - The company undertakes no obligation to update forward-looking statements, except as required by law[9](index=9&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) Provides Annovis Bio Inc.'s corporate address and investor contact details for inquiries - Company Address: 101 Lindenwood Drive, Suite 225, Malvern, PA 19355[11](index=11&type=chunk) - Investor Contact: Alexander Morin, Ph.D., Director of Strategic Communications, Email: ir@annovisbio.com[11](index=11&type=chunk)

Core Viewpoint - Annovis Bio, Inc. is advancing its pivotal Phase 3 trial for early Alzheimer's disease, with significant progress in patient enrollment and global intellectual property protection [2][6]. Clinical Highlights - The pivotal Phase 3 study in early Alzheimer's disease has secured 76 clinical sites in the U.S. and has screened over 400 patients, with 38 patients currently receiving treatment [2][6]. - The screen failure rate for the trial is as expected at 50% [6]. - Annovis presented four scientific posters at AAIC 2025, showcasing advancements in the Alzheimer's Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap [6]. Business Highlights - The company has successfully transferred all patent families to crystal buntanetap, achieving comprehensive global intellectual property coverage [2][6]. - Annovis welcomed a new Director of Biostatistics to maintain the statistical integrity of clinical trial data [6]. - A webcast was hosted in June to provide updates on the Phase 3 trial, allowing for direct engagement with the audience [6]. Financial Results - As of June 30, 2025, Annovis reported cash and cash equivalents of $17.1 million, an increase from $10.6 million as of December 31, 2024 [6]. - Research and development expenses for Q2 2025 were $5.2 million, down from $5.8 million in Q2 2024 [6]. - General and administrative expenses decreased to $1.1 million in Q2 2025 from $2.0 million in Q2 2024 [6]. - The net loss per common share for Q2 2025 was $0.32, an improvement from a loss of $0.44 per share in Q2 2024 [6].

Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing therapies for neurodegenerative diseases, particularly Alzheimer's disease and Parkinson's disease [1][4] - The company will present four scientific posters at the Alzheimer's Association International Conference (AAIC) from July 27–31, 2025, in Toronto, Canada, showcasing advancements in its Alzheimer's clinical program and pharmacokinetic studies of its lead drug candidate, buntanetap [1][2] Presentation Details - Poster 1 will discuss the design of a Phase III study testing the efficacy of buntanetap in early Alzheimer's patients, informed by insights from previous studies, presented by Cheng Fang, Ph.D. [2] - Poster 2 will detail a dual 6-month and 18-month randomized, placebo-controlled, double-blind pivotal clinical trial investigating the efficacy and safety of buntanetap in early Alzheimer's patients, presented by Sarah MacCallum [2] - Poster 3 will cover the comparative pharmacokinetic characterization of the original semi-crystalline and the novel crystalline form of buntanetap in both animals and humans, presented by Alexander Morin, Ph.D. [2] - Poster 4 will focus on the pharmacokinetic characterization of buntanetap in the plasma of patients with early Alzheimer's and Parkinson's diseases, presented by Matthew Peterson, Ph.D. [2] Conference Overview - The AAIC 2025 is recognized as the world's largest meeting dedicated to advancing the science and clinical practice of dementia, bringing together global researchers, clinicians, and professionals to share discoveries and insights aimed at improving the diagnosis, treatment, and care of individuals affected by Alzheimer's disease and other dementias [3]

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].