Adicet Bio(ACET) - 2024 Q1 - Quarterly Report

Clinical Development - The FDA cleared the IND application for ADI-001 in lupus nephritis, with a Phase 1 clinical trial expected to start in Q2 2024[96] - The potential market opportunity for ADI-001 in B cell mediated autoimmune diseases is substantial, with over 1.7 million patients in the U.S., EU5, China, and Japan[96] - ADI-001 showed an 80% overall response rate and 80% complete response rate in MCL patients during the GLEAN trial, with a favorable safety profile[98] - The company anticipates providing preliminary clinical data from the Phase 1 trial of ADI-001 in lupus nephritis in late 2024 or early 2025[97] - The company is considering expansion into additional CD70+ tumor indications for ADI-270 in the first half of 2025, with potential clinical data in the second half of 2025[100] Financial Performance - Net loss for the three months ended March 31, 2024, was $28.0 million, a decrease of$2.9 million, or 9%, from a net loss of $30.9 million in the same period in 2023[112] - The company has an accumulated deficit of$408.8 million as of March 31, 2024, and expects to continue incurring significant losses for the foreseeable future[123][124] - Research and development expenses decreased by $2.9 million, or 11$23.9 million for the three months ended March 31, 2024, compared to $26.8 million in the same period in 2023[112] - General and administrative expenses increased by$0.4 million, or 6%, to $7.0 million for the three months ended March 31, 2024, primarily due to an increase in stock-based compensation and salaries[114] - Interest income increased by$0.3 million, or 9%, to $2.9 million for the three months ended March 31, 2024, attributed to higher interest rates and investments in treasury securities[115] Cash Flow and Capital - As of March 31, 2024, the company had cash and cash equivalents of$247.6 million, expected to be sufficient to fund operations for at least the next twelve months[119] - The company raised approximately $91.7 million from an underwritten public offering of 32,379,667 shares at a public offering price of$2.40 per share[118] - Net cash used in operating activities was $22.8 million for the three months ended March 31, 2024, compared to$24.1 million for the same period in 2023[131][132] - The company recorded a net decrease in cash and cash equivalents of $87.9 million for the three months ended March 31, 2024, compared to a decrease of$26.0 million in the same period in 2023[130] - Net cash provided by financing activities was $111.0 million for the three months ended March 31, 2024, including approximately$91.7 million from common stock issuance[134] Operational Expenses - Research and development expenses are primarily related to employee costs, consultant agreements, and lab materials, with no products approved for commercial sale[105] - General and administrative expenses are expected to increase due to costs associated with operating as a public company and compliance with Nasdaq and SEC requirements[109] Leasing and Facilities - The company has a non-cancellable operating lease in Boston with an initial annual base rent of $0.6 million, increasing 2$1.3 million, increasing 3% annually, with an expiration date of February 28, 2030[137] - The company entered into a membership agreement for office space in Boston, effective February 1, 2024, expiring January 31, 2025[138] Market and Economic Factors - Inflation is expected to increase costs related to labor, clinical trials, and manufacturing, but it did not materially affect the company's financial condition during the three months ended March 31, 2024[145] - The company does not believe that foreign currency exchange rate fluctuations have had a significant impact on its results of operations[144] Regulatory and Reporting - The company remains a "smaller reporting company," allowing it to take advantage of reduced disclosure requirements[140] - There have been no material changes in critical accounting policies from those disclosed in the previous Annual Report[139]