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]

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].