Acumen Pharmaceuticals(ABOS) - 2023 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) Unaudited financial statements show total assets increased to $286.4 million due to a public offering, with a $35.9 million net loss for the first nine months of 2023 Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $94,917 | $130,101 | | Marketable securities (short & long-term) | $187,787 | $63,341 | | Total assets | $286,371 | $196,587 | | Total liabilities | $6,098 | $7,812 | | Total stockholders' equity | $280,273 | $188,775 | Condensed Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Research and development | $29,025 | $21,615 | | General and administrative | $13,627 | $9,374 | | Loss from operations | ($42,652) | ($30,989) | | Net loss | ($35,874) | ($29,990) | | Net loss per common share | ($0.79) | ($0.74) | Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,750) | ($23,950) | | Net cash (used in) provided by investing activities | ($122,864) | $59,605 | | Net cash provided by (used in) financing activities | $122,619 | ($277) | - In July 2023, the company completed a public offering, issuing 16,774,193 shares of common stock at $7.75 per share, resulting in net proceeds of $122.3 million after expenses[31] - Subsequent to the quarter end, the company entered a license agreement with Halozyme for ENHANZE® technology and a Loan and Security Agreement for up to $50.0 million in term loans[80][82] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses ACU193's clinical progress, a 38% rise in operating expenses, and strengthened liquidity from recent financing, extending cash runway to 2026 - The company announced positive topline results from its Phase 1 INTERCEPT-AD trial for ACU193 in July 2023, meeting primary objectives for safety and tolerability and showing evidence of target engagement in the brain, with plans to initiate a Phase 2/3 clinical study in the first half of 2024[89][91][94] Comparison of Operating Expenses (Nine Months Ended Sep 30, in thousands) | Expense Category | 2023 | 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $29,025 | $21,615 | $7,410 | 34% | | General and administrative | $13,627 | $9,374 | $4,253 | 45% | | Total operating expenses | $42,652 | $30,989 | $11,663 | 38% | - The $7.4 million increase in R&D expenses was primarily driven by higher personnel costs, services from contractors and consultants, and costs associated with planning for the upcoming Phase 2 clinical trial[116] - The $4.3 million increase in G&A expenses was mainly due to a $3.5 million rise in personnel costs, which included a $1.6 million increase in non-cash stock compensation, along with higher consulting and professional fees[117] - As of September 30, 2023, the company had $282.7 million in cash, cash equivalents, and marketable securities, with capital expected to fund operations and expenditures into the second half of 2026 after a subsequent $30.0 million loan tranche received in November 2023[99][121] Quantitative and Qualitative Disclosures About Market Risk As a "smaller reporting company," Acumen Pharmaceuticals is not required to provide market risk disclosures - Acumen Pharmaceuticals is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a "smaller reporting company" under SEC regulations[140] Controls and Procedures Management confirmed effective disclosure controls and no material changes to internal controls over financial reporting as of September 30, 2023 - Based on an evaluation as of September 30, 2023, the company's management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective[142] - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[144] PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings that would adversely affect its business - As of the filing date, the company is not subject to any material legal proceedings[148] Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes to the risk factors as described in the company's Annual Report on Form 10-K for the year ended December 31, 2022[149] Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities The company reports no unregistered equity sales or repurchases, with no material change in the planned use of IPO proceeds - The company reports no unregistered sales of equity securities or issuer purchases of its equity securities for the period[149][150] - There has been no material change in the planned use of the $168.6 million in net proceeds from the company's IPO, which closed in July 2021[150] Defaults Upon Senior Securities This item is not applicable to the company - Not applicable[151] Mine Safety Disclosures This item is not applicable to the company - Not applicable[151] Other Information The company secured up to $50.0 million in term loans via a Loan and Security Agreement on November 10, 2023, for working capital - On November 10, 2023, the company entered into a Loan and Security Agreement providing up to $50.0 million in term loans[152] - The loan consists of a first tranche of $30.0 million funded at closing and a second tranche of up to $20.0 million available subject to lender review and approval[152] - The loan bears a variable interest rate, matures on November 1, 2027 (extendable to 2028), and is secured by substantially all company assets, excluding intellectual property[153] Exhibits This section lists exhibits filed with the Form 10-Q, including officer certifications and XBRL documents - The report includes a list of exhibits filed, such as officer certifications under Sections 302 and 906 of the Sarbanes-Oxley Act and XBRL data files[158]