Annovis Bio(ANVS) - 2023 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION Financial Statements Unaudited financial statements for Q1 2023 are presented, including restated Q1 2022 figures, reflecting a $9.7 million net loss and cash decreasing to $16.8 million Balance Sheets The balance sheet as of March 31, 2023, reflects a decrease in total assets to $25.5 million and total stockholders' equity to $20.1 million, primarily due to reduced cash Balance Sheet Summary (in thousands) | Balance Sheet Items | March 31, 2023 (Unaudited) | December 31, 2022 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $16,758.8 | $28,377.7 | | Total current assets | $25,547.4 | $36,022.1 | | Total assets | $25,547.4 | $36,022.1 | | Liabilities & Equity | | | | Total current liabilities | $5,411.3 | $7,698.5 | | Total liabilities | $5,411.3 | $7,698.5 | | Total stockholders' equity | $20,136.1 | $28,323.5 | Statements of Operations The company reported a net loss of $9.7 million, or ($1.19) per share, for Q1 2023, primarily due to a significant increase in research and development expenses Statements of Operations Summary (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $7,786.1 | $2,149.6 | | General and administrative | $2,183.7 | $3,104.1 | | Total operating expenses | $9,969.7 | $5,253.7 | | Operating loss | ($9,969.7) | ($5,253.7) | | Net loss | ($9,737.2) | ($5,234.1) | | Basic and diluted loss per share | ($1.19) | ($0.64) | Statements of Changes in Stockholders' Equity Stockholders' equity decreased to $20.1 million as of March 31, 2023, primarily due to the $9.7 million net loss for the quarter - Total stockholders' equity decreased by approximately $8.2 million during the first quarter of 2023, mainly driven by the net loss for the period[15] Statements of Cash Flows Net cash used in operating activities significantly increased to $11.6 million for Q1 2023, leading to a decrease in cash and cash equivalents to $16.8 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,626.3) | ($3,021.8) | | Net cash provided by financing activities | $7.4 | $4.6 | | Net decrease in cash | ($11,618.9) | ($3,017.2) | | Cash at end of period | $16,758.8 | $42,668.8 | Notes to Financial Statements Detailed notes support the financial statements, disclosing the company's clinical-stage drug platform, a going concern warning, prior period restatement, and subsequent events - The company is a clinical-stage drug platform company focusing on neurodegeneration, such as Alzheimer's disease (AD) and Parkinson's disease (PD), with its lead product candidate, Buntanetap[19] - Management has concluded that substantial doubt exists about the Company's ability to continue as a going concern, as current cash is only sufficient to fund operations into the first quarter of 2024[21] - The company restated its Q1 2022 financial statements to correct for material errors in the timing and recognition of research and development expenses, which resulted in an overstatement of the previously reported net loss by $660,150[67][68] - Subsequent to the quarter end, the company terminated its At-the-Market (ATM) Equity Offering Sales Agreement after raising gross proceeds of $7.66 million and an additional $1.06 million through a private placement to board members and management[74][75] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses business strategy, financial results, and liquidity, highlighting Buntanetap's trial progress, increased R&D expenses, and a going concern warning due to insufficient capital - The company is advancing its lead product, Buntanetap, with a Phase 3 study in early Parkinson's disease (PD) patients initiated in August 2022 and a Phase 2/3 study in mild to moderate Alzheimer's disease (AD) patients initiated in February 2023[88] - The goal is to have conducted the required pivotal studies for Buntanetap to be able to file two new drug applications (NDAs) with the FDA by the end of 2026[90] - The company has insufficient capital to fund operations for the next 12 months and believes current cash will only be sufficient into the first quarter of 2024, leading to a going concern warning[105] Results of Operations Q1 2023 results show a $5.6 million increase in R&D expenses due to clinical trials, while G&A expenses decreased by $0.9 million primarily from reduced stock-based compensation Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $7,786.1 | $2,149.6 | +$5,636.5 | | General and administrative | $2,183.7 | $3,104.1 | -$920.4 | - The increase in R&D expenses was primarily driven by a $6.2 million increase in clinical expenses related to the ongoing Phase 3 PD and Phase 2/3 AD studies[96] - The decrease in G&A expenses was mainly due to a $1.5 million decrease in stock-based compensation expense[97] Liquidity and Capital Resources Liquidity significantly decreased in Q1 2023, with cash falling to $16.8 million and net cash used in operations surging to $11.6 million, necessitating additional capital - As of March 31, 2023, the company's principal source of liquidity was cash totaling $16.8 million[99] - Cash used in operations increased by $8.6 million in Q1 2023 compared to Q1 2022, primarily due to an increase in cash paid for clinical trial expenses[103] - The company states it does not have sufficient capital for the next 12 months and will need to raise additional funds through equity or debt offerings, collaborations, or other financing alternatives to complete the development of its product candidates[105] Quantitative and Qualitative Disclosure About Market Risk This disclosure is not required for smaller reporting companies - This item is not required for smaller reporting companies[110] Controls and Procedures Management concluded disclosure controls and procedures were ineffective as of March 31, 2023, due to a material weakness in internal control over financial reporting, leading to a restatement and ongoing remediation - Management concluded that disclosure controls and procedures were not effective as of the end of the period covered by the report[110] - A material weakness was identified in internal control over financial reporting related to the proper classification of research and development expenses[111][112] - A remediation plan is underway, which includes enhancing review procedures over significant contracts, augmenting staff, and strengthening the review process[115] PART II – OTHER INFORMATION Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[118] Risk Factors This item is not required for smaller reporting companies in their Form 10-Q - This item is not required for smaller reporting companies[118] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported during the period - None reported[118] Exhibits This section lists exhibits filed with the Form 10-Q, including corporate governance documents, the terminated ATM Sales Agreement, and Sarbanes-Oxley certifications - Exhibits filed include corporate governance documents, the terminated ATM Sales Agreement, and Sarbanes-Oxley certifications[120]