Annovis Bio(ANVS) - 2025 Q2 - Quarterly Results

Report Overview 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 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] - The company provided its latest corporate updates and Q2 2025 financial results on August 12, 2025[1] CEO Statement 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] - Latest scientific discoveries were presented at AAIC 2025[2] - Global intellectual property protection was strengthened by completing the transfer of all patent families to crystalline buntanetap[2] Corporate Updates Annovis made significant strides in clinical trials, patient enrollment, and intellectual property protection, alongside key scientific presentations and business communications Clinical Highlights 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] - 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] - In April, Annovis hired Hui Liu as Director of Biostatistics[4] - In July, senior Annovis members attended AAIC 2025, presenting four scientific posters highlighting Alzheimer's disease Phase III study and buntanetap pharmacokinetics progress[4] Business Highlights 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] - 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] Second Quarter 2025 Financial Results 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 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 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 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. Annovis Bio, Inc. is a clinical-stage pharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases About Annovis Bio, Inc. 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] - The company is dedicated to addressing neurodegeneration in diseases such as AD and PD[7] - Annovis is committed to developing innovative therapies to improve patient outcomes and quality of life[7] Additional Information This section provides important disclosures regarding investor communications, forward-looking statements, and company contact details Investor Alerts 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] Forward-Looking Statements 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] - 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] - The company undertakes no obligation to update forward-looking statements, except as required by law[9] Contact Information Provides Annovis Bio Inc.'s corporate address and investor contact details for inquiries - Company Address: 101 Lindenwood Drive, Suite 225, Malvern, PA 19355[11] - Investor Contact: Alexander Morin, Ph.D., Director of Strategic Communications, Email: ir@annovisbio.com[11]