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]

PART I – FINANCIAL INFORMATION This section presents the unaudited interim financial statements and management's discussion and analysis of Annovis Bio, Inc. [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited interim financial statements of Annovis Bio, Inc., including the Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity (Deficit), Statements of Cash Flows, and accompanying Notes to Financial Statements for the periods ended June 30, 2025 and 2024 [Balance Sheets](index=4&type=section&id=Balance%20Sheets) This section provides a comparative overview of the company's financial position as of June 30, 2025, and December 31, 2024 Balance Sheet Highlights (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :--------------------------------- | :-------------- | :---------------- | :----- | :------- | | Cash and cash equivalents | $17,130,286 | $10,551,916 | $6,578,370 | 62.3% | | Total assets | $21,454,571 | $13,925,633 | $7,528,938 | 54.1% | | Total current liabilities | $2,805,124 | $3,880,987 | $(1,075,863) | -27.7% | | Warrant liability | $319,000 | $737,000 | $(418,000) | -56.7% | | Total liabilities | $3,124,124 | $4,617,987 | $(1,493,863) | -32.3% | | Total stockholders' equity | $18,330,447 | $9,307,646 | $9,022,801 | 96.9% | [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) This section details the company's financial performance, including revenues, expenses, and net loss, for the three and six months ended June 30, 2025 and 2024 Statements of Operations Highlights (Three Months Ended June 30) | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------- | :-------------- | :-------------- | :----- | | Research and development | $5,161,921 | $5,785,217 | $(623,296) | | General and administrative | $1,109,532 | $1,977,421 | $(867,889) | | Total operating expenses | $6,271,453 | $7,762,638 | $(1,491,185) | | Operating loss | $(6,271,453) | $(7,762,638) | $1,491,185 | | Interest income | $191,395 | $25,978 | $165,417 | | Change in fair value of warrants | $(140,000) | $4,062,308 | $(4,202,308) | | Net loss | $(6,220,058) | $(5,020,412) | $(1,199,646) | | Basic Net loss per share | $(0.32) | $(0.44) | $0.12 | | Diluted Net loss per share | $(0.32) | $(0.44) | $0.12 | Statements of Operations Highlights (Six Months Ended June 30) | Metric | June 30, 2025 | June 30, 2024 | Change | | :-------------------------- | :-------------- | :-------------- | :----- | | Research and development | $10,173,438 | $12,307,308 | $(2,133,870) | | General and administrative | $2,380,696 | $3,265,137 | $(884,441) | | Total operating expenses | $12,554,134 | $15,572,445 | $(3,018,311) | | Operating loss | $(12,554,134) | $(15,572,445) | $3,018,311 | | Interest income | $379,007 | $70,146 | $308,861 | | Change in fair value of warrants | $418,000 | $10,761,000 | $(10,343,000) | | Net loss | $(11,757,127) | $(6,087,359) | $(5,669,768) | | Basic Net loss per share | $(0.64) | $(0.56) | $(0.08) | | Diluted Net loss per share | $(0.64) | $(1.52) | $0.88 | [Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29) This section outlines the changes in the company's equity structure, including stock issuances and net loss, for the periods ended June 30, 2025 and 2024 Stockholders' Equity Changes (Six Months Ended June 30, 2025) | Item | Amount (June 30, 2025) | | :------------------------------------------------ | :------------------- | | Balance, December 31, 2024 | $9,307,646 | | Issuance of common stock (Equity Distribution) | $502,934 | | Issuance of common stock and warrants (Registered Offering) | $19,280,489 | | Stock-based compensation expense | $996,505 | | Net loss | $(11,757,127) | | Balance, June 30, 2025 | $18,330,447 | Stockholders' Equity Changes (Six Months Ended June 30, 2024) | Item | Amount (June 30, 2024) | | :------------------------------------------------ | :------------------- | | Balance, December 31, 2023 | $(7,750,846) | | Exercise of common stock warrants | $1,224,000 | | Issuance of common stock | $3,875,000 | | Stock-based compensation expense | $1,961,277 | | Net loss | $(6,087,359) | | Balance, June 30, 2024 | $(1,750,884) | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Cash Flow Summary (Six Months Ended June 30) | Activity | June 30, 2025 | June 30, 2024 | | :--------------------------------------- | :-------------- | :-------------- | | Net cash used in operating activities | $(13,205,053) | $(10,407,937) | | Net cash provided by financing activities | $19,783,423 | $8,650,984 | | Net increase (decrease) in cash | $6,578,370 | $(1,756,953) | | Cash and cash equivalents, end of period | $17,130,286 | $3,997,767 | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) This section provides detailed disclosures and explanations for the figures presented in the financial statements, covering the company's business, significant accounting policies, fair value measurements, and specific financial line items [1. Nature of Business, Going Concern and Management's Plan](index=8&type=section&id=%281%29%20Nature%20of%20Business%2C%20Going%20Concern%20and%20Management%27s%20Plan) Annovis Bio, Inc. is a late-stage clinical drug platform company focused on neurodegeneration, particularly Alzheimer's and Parkinson's diseases, with its lead product candidate, buntanetap. The company has a history of net losses and negative cash flows, leading management to conclude that substantial doubt exists about its ability to continue as a going concern for the next year without raising additional capital - Annovis Bio, Inc. is a late-stage clinical drug platform company developing buntanetap for neurodegenerative diseases like AD and PD. Buntanetap is designed to inhibit multiple neurotoxic proteins and improve axonal transport[23](index=23&type=chunk) - The company has incurred significant net losses and negative cash flows since inception, with an accumulated deficit of **$146.6 million** as of June 30, 2025. Net loss for the six months ended June 30, 2025, was **$11.8 million**, compared to **$6.1 million** in 2024[26](index=26&type=chunk) - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern for one year after the filing date, as existing cash (**$17.1 million** as of June 30, 2025) is insufficient. Plans to mitigate this risk include raising additional capital through equity financings, debt, or other potential alternatives, and deferring certain operating expenses[26](index=26&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=%282%29%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the significant accounting policies used in preparing the interim financial statements, including the basis of presentation, use of estimates, calculation of basic and diluted net loss per share, treatment of cash and cash equivalents, equity issuance costs, derivative liabilities, common stock warrants, fair value measurements, research and development expenses, stock-based compensation, and income taxes. It also mentions recent accounting pronouncements - The financial statements are unaudited and prepared in conformity with U.S. GAAP, including normal, recurring adjustments. Management makes estimates and assumptions, particularly for equity instruments, warrant liabilities, derivative liabilities, and R&D contracts[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - Common stock warrants are classified as liabilities if they contain cash settlement adjustment features outside the company's control or not deemed to be indexed to its stock, requiring re-measurement at fair value each balance sheet date[35](index=35&type=chunk) - Research and development costs are expensed as incurred or recorded as prepaid assets, with estimates based on patient enrollment, project milestones, and vendor efforts. Stock-based compensation is recognized based on grant date fair values using the Black-Scholes model[37](index=37&type=chunk)[38](index=38&type=chunk) - The company has a full valuation allowance against its deferred tax assets due to the unlikelihood of realization. Recent accounting pronouncements (ASU 2023-09 and ASU 2024-03) are being evaluated for potential impacts on future disclosures[44](index=44&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk) [3. Fair Value Measurements](index=16&type=section&id=%283%29%20Fair%20Value%20Measurements) This note details the fair value measurements of the company's financial instruments, primarily focusing on the warrant liability. It explains the three-level fair value hierarchy and how the Canaccord Warrants, classified as Level 3 liabilities, are valued using a Black-Scholes option-pricing model after certain performance conditions were not met Fair Value Measurement of Warrant Liability (June 30, 2025 vs. December 31, 2024) | Item | June 30, 2025 (Level 3) | December 31, 2024 (Level 3) | | :---------------- | :---------------------- | :------------------------ | | Warrant liability | $319,000 | $737,000 | - The Canaccord Warrants are classified as Level 3 liabilities due to unobservable inputs and are valued using a Black-Scholes option-pricing model. Key inputs include an exercise price of **$9.00**, closing stock price of **$2.17** (June 30, 2025), volatility of **113%**, term of **3.34 years**, and a risk-free rate of **3.7%**[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - During Q3 2024, it was determined that performance conditions for redemption of Canaccord Warrants (positive topline data from Phase 3 PD study and stock price/ADTV thresholds) were not met, leading to a change in valuation model from Monte Carlo to Black-Scholes[53](index=53&type=chunk)[56](index=56&type=chunk)[59](index=59&type=chunk) [4. Prepaid Expenses and Other Current Assets](index=18&type=section&id=%284%29%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note provides a breakdown of the company's prepaid expenses and other current assets, primarily consisting of prepaid clinical expenses Prepaid Expenses and Other Current Assets (June 30, 2025 vs. December 31, 2024) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Prepaid clinical expenses | $3,846,146 | $2,998,811 | | Prepaid other | $393,812 | $346,313 | | Prepaid insurance | $76,832 | $21,098 | | Security deposits | $7,495 | $7,495 | | Total prepaid expenses and other current assets | $4,324,285 | $3,373,717 | [5. Accrued Expenses](index=18&type=section&id=%285%29%20Accrued%20Expenses) This note details the composition of accrued expenses, which include accrued clinical expenses, payroll and related benefits, and accrued professional and other fees Accrued Expenses (June 30, 2025 vs. December 31, 2024) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Accrued clinical expenses | $1,070,293 | $948,695 | | Payroll and related benefits | $526,890 | $364,717 | | Accrued professional and other | $233,630 | $261,601 | | Total accrued expenses | $1,830,813 | $1,575,013 | [6. Commitments and Contingencies](index=19&type=section&id=%286%29%20Commitments%20and%20Contingencies) This note outlines the company's various commitments and contingencies, including contracts with CROs and CMOs for clinical trials, a short-term lease for its corporate headquarters, an employment agreement with its CEO, and potential litigation - The company has contracts with CROs and CMOs for clinical trials, requiring upfront, milestone, and pass-through payments. These contracts are generally cancellable with notice, but payments for services rendered are obligatory[60](index=60&type=chunk) - Total rental expense for the corporate headquarters lease was **$24,844** for Q2 2025 and **$57,582** for the six months ended June 30, 2025[61](index=61&type=chunk) - An employment agreement with the CEO provides for estimated maximum severance payments of **$1.2 million** at June 30, 2025, under specific termination conditions[62](index=62&type=chunk) [7. Stockholders' Equity](index=19&type=section&id=%287%29%20Stockholders%27%20Equity) This note details the company's capital structure, including authorized common and preferred stock, and various equity and warrant issuances. It covers the February 2025 ThinkEquity offering, November 2023 Canaccord offering, IPO warrants, December 2024 ATM facility, and the exhausted 2024 ELOC Purchase Agreement, along with the roll-forward of the common stock warrant liability - The company's authorized capital includes **70.0 million** shares of common stock and **2.0 million** shares of preferred stock, both with a **$0.0001** par value. No preferred stock was outstanding as of June 30, 2025[64](index=64&type=chunk)[68](index=68&type=chunk) - In February 2025, the company completed an underwritten public offering, issuing **5.3 million** units (common stock + ThinkEquity Warrants) for net proceeds of **$19.3 million**. ThinkEquity Warrants are equity-classified, exercisable at **$5.00**, and expire in February 2030[69](index=69&type=chunk)[70](index=70&type=chunk) - The Canaccord Warrants (from November 2023 offering) are liability-classified due to cash settlement features. The warrant liability decreased from **$737,000** at December 31, 2024, to **$319,000** at June 30, 2025, primarily due to changes in fair value[71](index=71&type=chunk)[72](index=72&type=chunk) Common Stock Warrants Outstanding (June 30, 2025) | Warrant Type | Classification | Outstanding (June 30, 2025) | Exercise Price | Expiration Date | | :------------- | :------------- | :-------------------------- | :------------- | :-------------- | | ThinkEquity | Equity | 5,250,000 | $5.00 | Feb 4, 2030 | | Canaccord | Liability | 308,333 | $9.00 | Nov 2, 2028 | | IPO | Equity | 0 | $7.50 | Jan 29, 2025 | [8. Stock-Based Compensation](index=23&type=section&id=%288%29%20Stock-Based%20Compensation) This note details the company's stock-based compensation, primarily through stock options under the 2019 Equity Incentive Plan. It provides the stock-based compensation expense recognized and summarizes stock option activity, including grants and expirations - The 2019 Equity Incentive Plan was amended in June 2024 to increase authorized shares from **2.0 million** to **3.0 million**. As of June 30, 2025, **0.4 million** shares were available for future grants[82](index=82&type=chunk) Stock-Based Compensation Expense (Three and Six Months Ended June 30) | Expense Category | Q2 2025 (USD) | Q2 2024 (USD) | YTD 2025 (USD) | YTD 2024 (USD) | | :----------------------- | :------ | :------ | :------- | :------- | | General and administrative | $270,395 | $997,779 | $537,333 | $1,233,519 | | Research and development | $226,223 | $598,733 | $459,172 | $727,758 | | Total | $496,618 | $1,596,512 | $996,505 | $1,961,277 | Stock Option Activity (December 31, 2024 to June 30, 2025) | Item | Number of Options | Weighted Average Exercise Price | | :-------------------------------- | :---------------- | :------------------------------ | | Options outstanding at Dec 31, 2024 | 2,336,020 | $11.39 | | Options granted | 20,000 | $1.64 | | Options expired | (92,562) | $10.12 | | Options outstanding at Jun 30, 2025 | 2,263,458 | $11.36 | | Options exercisable at Jun 30, 2025 | 1,912,281 | $12.34 | [9. Net Loss Per Share](index=24&type=section&id=%289%29%20Net%20Loss%20Per%20Share) This note presents the computation of basic and diluted net loss per common share, detailing the numerator (net loss) and denominator (weighted-average common shares outstanding) for both basic and diluted calculations. It also lists potentially antidilutive securities excluded from diluted EPS Net Loss Per Share (Three and Six Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :-------------------------- | :------ | :------ | :------- | :------- | | Basic net loss per common share | $(0.32) | $(0.44) | $(0.64) | $(0.56) | | Diluted net loss per common share | $(0.32) | $(0.44) | $(0.64) | $(1.52) | Antidilutive Securities Excluded from Diluted EPS (June 30) | Security Type | 2025 | 2024 | | :-------------- | :---------- | :---------- | | Stock options | 2,263,458 | 2,254,747 | | ELOC shares | — | 1,317,491 | | Warrants | 5,558,333 | 2,400 | | Restricted stock | 25,000 | — | [10. Income Taxes](index=24&type=section&id=%2810%29%20Income%20Taxes) This note states that the company recorded no income tax benefit or expense for the periods presented due to a full valuation allowance against its deferred tax assets. It also mentions potential limitations on net operating loss carryforwards due to ownership changes - The company's income tax benefit (expense) was **$0** for the three and six months ended June 30, 2025 and 2024, due to a full valuation allowance against its deferred tax assets[88](index=88&type=chunk) - Net operating loss and tax credit carryforwards may be subject to annual limitations if there are cumulative changes in ownership interest exceeding **50%** over a three-year period, as defined by Sections 382 and 383 of the Internal Revenue Code[89](index=89&type=chunk) [11. Segment Information](index=26&type=section&id=%2811%29%20Segment%20Information) The company operates as a single reportable segment, focusing on the discovery, development, and commercialization of buntanetap for neurodegenerative diseases. The Chief Operating Decision Maker (CODM) assesses performance and allocates resources based on net loss and monitors specific expense categories - Annovis Bio operates as a single reportable segment, encompassing all activities related to the development of buntanetap for AD, PD, and other neurodegenerative diseases[91](index=91&type=chunk) Segment Expense Categories (Three and Six Months Ended June 30) | Expense Category | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--------------------------------------- | :---------- | :---------- | :----------- | :----------- | | Program expenses (clinical stage) | $(4,228,642) | $(4,676,084) | $(8,445,857) | $(10,588,112) | | Program expenses (preclinical/discovery) | $(49,714) | $(169,176) | $(80,313) | $(277,514) | | Personnel-related expenses | $(1,496,642) | $(2,333,028) | $(2,894,516) | $(3,527,715) | | General and administrative professional fees | $(292,649) | $(389,485) | $(737,514) | $(758,838) | | Other segment items | $(203,806) | $(194,865) | $(395,934) | $(420,266) | | Interest income | $191,395 | $25,978 | $379,007 | $70,146 | | Other non-cash income (expense) items | $(140,000) | $2,716,248 | $418,000 | $9,414,940 | | Net Loss | $(6,220,058) | $(5,020,412) | $(11,757,127) | $(6,087,359) | [12. Subsequent Events](index=28&type=section&id=%2812%29%20Subsequent%20Events) This note indicates that there were no subsequent events requiring disclosure - No subsequent events were reported[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, changes in results of operations, and liquidity for the periods presented. It includes a cautionary note on forward-looking statements, an overview of the company's business and clinical development, funding requirements, and a detailed comparison of financial results [Cautionary Note Regarding Forward-Looking Statements](index=29&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section advises readers that the report contains forward-looking statements subject to various risks and uncertainties, and the company undertakes no obligation to update them - The report contains forward-looking statements subject to substantial risks and uncertainties, including those related to cash needs, business strategies, regulatory approvals, clinical trial timing and costs, market acceptance, reliance on third parties, competitive position, market size assumptions, intellectual property, financial results, and industry trends[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Readers are cautioned not to rely on forward-looking statements as predictions of future events and the company undertakes no obligation to update them, except as required by law[99](index=99&type=chunk)[100](index=100&type=chunk) [Company Overview](index=31&type=section&id=Company%20Overview) Annovis Bio is a late-stage clinical drug platform company developing buntanetap for neurodegenerative diseases, with promising clinical trial results and an ongoing Phase 3 AD trial - Annovis Bio is a late-stage clinical drug platform company focused on neurodegeneration (AD, PD) with its lead product candidate, buntanetap. Buntanetap is an orally administered small molecule designed to inhibit multiple neurotoxic proteins (APP/Aβ, tau/phospho-tau, α-Synuclein) to restore axonal and synaptic activity[102](index=102&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) - Completed Phase 1/2 clinical studies in AD and PD patients showed buntanetap lowered neurotoxic protein levels, improved axonal transport, reduced inflammation, and improved cognition in AD (ADAS-Cog) and motor function in PD (MDS-UPDRS)[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - The Phase 3 PD Study was completed in December 2023, with topline efficacy data released in July 2024 showing improvements in UPDRS and cognition in subgroups. The FDA approved an open-label study for PD patients[107](index=107&type=chunk)[108](index=108&type=chunk) - The Phase 2/3 AD study was completed in February 2024, with topline data in April 2024 showing dose-dependent, statistically significant improvement in ADAS-Cog11 in early AD patients. The FDA has aligned on a development path for buntanetap towards NDA filings for short-term and long-term efficacy[109](index=109&type=chunk)[110](index=110&type=chunk) - A pivotal FDA-cleared ANVS-25001 Phase 3 trial in early AD patients was initiated in February 2025, with a 6-month period for symptomatic efficacy and an additional 12 months for potential disease-modifying efficacy. The trial will use ADAS-Cog13, ADCS-iADL, volumetric MRI, and plasma biomarkers[111](index=111&type=chunk)[112](index=112&type=chunk) [Funding Requirements](index=35&type=section&id=Funding%20Requirements) The company has an accumulated deficit and insufficient cash to fund operations for the next year, necessitating substantial additional capital - The company has an accumulated deficit of **$146.6 million** as of June 30, 2025, and expects to incur further losses. Existing cash and cash equivalents (**$17.1 million**) are only sufficient to fund operations until Q1 2026[116](index=116&type=chunk)[117](index=117&type=chunk) - Substantial additional capital is required to complete product development and commercialization, to be raised through public/private equity, debt, or collaboration/licensing arrangements. There is no assurance that such capital will be available on acceptable terms[117](index=117&type=chunk)[118](index=118&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's operating results for the three and six months ended June 30, 2025, and 2024, highlighting changes in research and development expenses, general and administrative expenses, interest income, other financing costs, and the change in fair value of warrants [Comparison of the Three Months Ended June 30, 2025 and 2024](index=36&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024%20%283%20Months%29) For the three months ended June 30, 2025, total operating expenses decreased by $1.5 million, primarily due to lower R&D and G&A expenses. Net loss increased by $1.2 million, mainly driven by a significant decrease in the gain from the change in fair value of warrants Operating Results (Three Months Ended June 30) | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------- | :--------------------------- | :--------------------------- | :-------------------- | | Research and development | $5,162 | $5,785 | $(623) | | General and administrative | $1,110 | $1,977 | $(867) | | Total operating expense | $6,272 | $7,762 | $(1,490) | | Interest income | $191 | $26 | $165 | | Other financing costs | $0 | $(1,346) | $1,346 | | Change in fair value of warrants | $(140) | $4,062 | $(4,202) | | Net loss | $(6,221) | $(5,020) | $(1,201) | - Research and development expenses decreased by **$0.6 million**, mainly due to **$2.5 million** lower contract manufacturing and drug substance costs, partially offset by **$1.9 million** higher clinical labor and pass-through costs for the Phase 3 AD program[121](index=121&type=chunk) - General and administrative expenses decreased by **$0.9 million**, primarily due to **$0.7 million** lower stock-based compensation and **$0.2 million** reduced corporate legal, printing, and public relations fees[123](index=123&type=chunk) - Interest income increased by **$0.2 million** due to higher cash and cash equivalent balances from the February 2025 public offering. Other financing costs decreased by **$1.3 million** as the 2024 ELOC facility was exhausted[124](index=124&type=chunk)[125](index=125&type=chunk) - The change in fair value of warrants resulted in a **$0.1 million loss** in Q2 2025, compared to a **$4.1 million gain** in Q2 2024, a **$4.2 million difference** driven by increased stock price volatility in Q2 2024[126](index=126&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=37&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20%286%20Months%29) For the six months ended June 30, 2025, total operating expenses decreased by $3.0 million, driven by lower R&D and G&A. However, net loss significantly increased by $5.7 million, primarily due to a substantial reduction in the gain from the change in fair value of warrants compared to the prior year Operating Results (Six Months Ended June 30) | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------- | :--------------------------- | :--------------------------- | :-------------------- | | Research and development | $10,173 | $12,307 | $(2,134) | | General and administrative | $2,381 | $3,265 | $(884) | | Total operating expense | $12,554 | $15,572 | $(3,018) | | Interest income | $379 | $70 | $309 | | Other financing costs | $0 | $(1,346) | $1,346 | | Change in fair value of warrants | $418 | $10,761 | $(10,343) | | Net loss | $(11,757) | $(6,087) | $(5,670) | - Research and development expenses decreased by **$2.1 million**, primarily due to a **$6.5 million** decrease in costs for completed Phase 3 PD and Phase 2/3 AD studies and a **$1.1 million** decrease in clinical material manufacturing, offset by **$4.7 million** increased costs for the active Phase 3 AD program and **$0.8 million** in clinical support costs[128](index=128&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk) - General and administrative expenses decreased by **$0.9 million**, mainly from a **$0.7 million** decrease in stock-based compensation and **$0.2 million** in reduced employee salary costs[131](index=131&type=chunk) - Interest income increased by **$0.3 million** due to higher cash balances from the February 2025 public offering. Other financing costs decreased by **$1.3 million** as the 2024 ELOC facility was exhausted[132](index=132&type=chunk)[133](index=133&type=chunk) - The change in fair value of warrants resulted in a **$0.4 million gain** in YTD 2025, significantly lower than the **$10.8 million gain** in YTD 2024, a **$10.4 million difference** primarily due to higher stock price volatility in the first half of 2024[134](index=134&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's sources and uses of cash, highlighting its reliance on equity and warrant sales for funding. It details recent financing activities, cash flow trends, and the ongoing need for additional capital to support operations and clinical trials - Since inception, the company has primarily financed operations through common stock and warrant sales, incurring losses and negative cash flows. As of June 30, 2025, cash and cash equivalents totaled **$17.1 million**, which is not sufficient to fund operations for the next twelve months[135](index=135&type=chunk) - In February 2025, a public offering with ThinkEquity generated **$19.3 million** in net proceeds from the sale of **5.3 million** units (common stock and warrants)[136](index=136&type=chunk) - Through the December 2024 ATM facility with Oppenheimer & Co. Inc., the company sold **0.1 million** shares of common stock for gross proceeds of **$0.5 million** during the six months ended June 30, 2025[137](index=137&type=chunk)[138](index=138&type=chunk) Cash Flow Summary (Six Months Ended June 30) | Activity | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :--------------------------------------- | :--------------------------- | :--------------------------- | | Operating activities | $(13,205) | $(10,408) | | Financing activities | $19,783 | $8,651 | | Net increase (decrease) in cash | $6,578 | $(1,757) | - Cash used in operating activities increased by **$2.8 million** to **$13.2 million** for the six months ended June 30, 2025, driven by additional cash paid for clinical trials and related expenses, with elevated burn expected due to the active Phase 3 AD trial[140](index=140&type=chunk)[141](index=141&type=chunk) - Cash provided by financing activities increased to **$19.8 million** in YTD 2025 (from **$8.7 million** in YTD 2024), mainly from the ThinkEquity offering and ATM facility, compared to proceeds from registered direct offerings, ELOC, and warrant exercises in the prior year[142](index=142&type=chunk) [February 2025 ThinkEquity Underwritten Offering](index=39&type=section&id=February%202025%20ThinkEquity%20Underwritten%20Offering) Details the February 2025 public offering where the company sold 5.3 million units, each consisting of common stock and a warrant, generating $19.3 million in net proceeds - On February 3, 2025, the company completed an underwritten public offering of **5.3 million** units (common stock and ThinkEquity Warrants) at **$4.00** per unit, resulting in gross proceeds of **$21.0 million** and net proceeds of **$19.3 million**[136](index=136&type=chunk) [December 2024 ATM](index=40&type=section&id=December%202024%20ATM) Describes the Equity Distribution Agreement established in December 2024, allowing the company to sell up to $50.0 million of common stock through Oppenheimer & Co. Inc., and the proceeds generated during the current period - The company entered into an Equity Distribution Agreement in December 2024 to sell up to **$50.0 million** of common stock through Oppenheimer & Co. Inc. During the six months ended June 30, 2025, **0.1 million** shares were sold for **$0.5 million** in gross proceeds[137](index=137&type=chunk)[138](index=138&type=chunk) [Cash Flows](index=40&type=section&id=Cash%20Flows) Provides a summary table of cash flows from operating and financing activities for the six months ended June 30, 2025 and 2024 Cash Flow Summary (Six Months Ended June 30) | Activity | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :--------------------------------------- | :--------------------------- | :--------------------------- | | Operating activities | $(13,205) | $(10,408) | | Financing activities | $19,783 | $8,651 | | Net increase (decrease) in cash | $6,578 | $(1,757) | [Operating Activities](index=40&type=section&id=Operating%20Activities) Explains the increase in cash used in operating activities, primarily due to higher clinical trial expenses, and anticipates continued elevated cash burn - Cash used in operating activities increased by **$2.8 million** to **$13.2 million** for the six months ended June 30, 2025, driven by additional cash paid for clinical trials and related expenses. Elevated operating cash burn is expected due to costs associated with the active Phase 3 AD trial[140](index=140&type=chunk)[141](index=141&type=chunk) [Financing Activities](index=40&type=section&id=Financing%20Activities) Details the sources of cash provided by financing activities, primarily from the ThinkEquity offering and ATM facility in 2025, contrasting with prior year sources - Cash provided by financing activities was **$19.8 million** for the six months ended June 30, 2025, mainly from **$19.3 million** in proceeds from the ThinkEquity registered offering and **$0.5 million** from the ATM facility. In 2024, financing activities provided **$8.7 million** from registered direct offerings, ELOC facility, and warrant exercises[142](index=142&type=chunk) [Contractual Obligations and Other Commitments](index=40&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) This section is not required for smaller reporting companies - This item is not required for smaller reporting companies[143](index=143&type=chunk) [Factors that May Affect Future Results](index=40&type=section&id=Factors%20that%20May%20Affect%20Future%20Results) Refers to the comprehensive discussion of risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2024, with no material changes noted - Important factors that may affect future results are discussed in Part I, Item 1A 'Risk Factors' of the Annual Report on Form 10-K for the year ended December 31, 2024. No material changes to these disclosures have occurred[144](index=144&type=chunk) [Off-Balance Sheet Arrangements](index=42&type=section&id=Off-Balance%20Sheet%20Arrangements) The company reports having no off-balance sheet arrangements - The company does not have any off-balance sheet arrangements[145](index=145&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=42&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) States that there were no significant changes to the critical accounting policies from those described in the 2024 Annual Report on Form 10-K - No significant changes were made to the critical accounting policies from those described in the Annual Report on Form 10-K for the year ended December 31, 2024[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) This item is not required for smaller reporting companies - This item is not required for smaller reporting companies[147](index=147&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and procedures and any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=42&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025 - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective as of June 30, 2025, ensuring timely and accurate reporting of information[148](index=148&type=chunk) [Changes in Internal Control Over Financial Reporting](index=42&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) No material changes in internal control over financial reporting were identified during the period - No changes in internal control over financial reporting were identified during the period that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[149](index=149&type=chunk) PART II – OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business, operating results, or financial condition - The company is not currently a party to any legal proceedings that are believed to have a material adverse effect on its business, operating results, or financial condition, and is unaware of any pending or threatened proceedings[152](index=152&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) Refers to the risk factors discussed in the company's Annual Report on Form 10-K, noting no material changes - Risk factors are discussed in Item 1A 'Risk Factors' of the Annual Report on Form 10-K filed on March 21, 2025, with no material changes to these disclosures[153](index=153&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds were reported[154](index=154&type=chunk) [Item 3. Defaults Upon Senior Securities](index=43&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - No defaults upon senior securities were reported[155](index=155&type=chunk) [Item 4. Mine Safety Disclosures](index=43&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[156](index=156&type=chunk) [Item 5. Other Information](index=43&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading plans during the three months ended June 30, 2025 - No directors or officers adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading plans during the three months ended June 30, 2025[157](index=157&type=chunk) [Item 6. Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents, certifications, and XBRL-related documents - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Certifications of Principal Executive and Financial Officers (31.1, 31.2, 32.1), and XBRL Instance, Schema, Calculation, Definition, Labels, and Presentation Linkbase Documents[159](index=159&type=chunk) [Signatures](index=45&type=section&id=Signatures) The report is signed by the President and Chief Executive Officer, Maria Maccecchini, and the Vice President Finance, Andrew Walsh, on August 12, 2025 - The report was signed by Maria Maccecchini, President and Chief Executive Officer, and Andrew Walsh, Vice President Finance, on August 12, 2025[162](index=162&type=chunk)

[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]