Lisata Therapeutics(US:LSTA)2024-03-01 01:41Financial Data and Key Metrics Changes - For the year ended December 31, 2023, operating expenses totaled $25.7 million, a decrease of $31.9 million or 55.4% compared to $57.6 million in 2022 [47] - Net losses were $20.8 million for 2023, down from $54.2 million in 2022 [50] - Cash, cash equivalents, and marketable securities as of December 31, 2023, were approximately $50.5 million, expected to fund operations into early 2026 [51] Business Line Data and Key Metrics Changes - Research and development expenses were approximately $12.7 million for 2023, a slight decrease of $300,000 or 2.5% from $13.1 million in 2022, primarily due to lower costs associated with LSTA1 programs [49] - General and administrative expenses were approximately $13 million for 2023, down from $14.1 million in 2022, representing a decrease of approximately $1.2 million or 8.3% [67] Market Data and Key Metrics Changes - The ASCEND trial has achieved full enrollment of 98 patients, with top-line data expected in Q4 2024 and complete data by mid-2025 [27] - The BOLSTER trial is on track for enrollment completion by the end of 2024, with the U.S. being the largest contributor to enrollment so far [30][36] Company Strategy and Development Direction - The company is focused on advancing LSTA1 rapidly toward registration in metastatic pancreatic ductal adenocarcinoma (mPDAC) and demonstrating its broad application in combination with various anti-cancer agents [24] - The strategy includes efficient and timely study execution to achieve meaningful clinical data readouts as soon as possible [25] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of generating meaningful clinical data efficiently, which is critical in the oncology field [52] - The company is optimistic about the potential of LSTA1 to become an integral part of revised standard care treatment regimens for difficult-to-treat cancers [46] Other Important Information - LSTA1 has received multiple orphan drug designations, including for pancreatic cancer and malignant glioma [60] - The company is conducting nearly a dozen planned or active clinical trials globally for various solid tumors [39] Q&A Session Summary Question: Insights on BOLSTER trial enrollment - Management confirmed that BOLSTER is on track to meet its enrollment goal by the end of 2024, with the U.S. being the largest contributor so far [36] Question: R&D credits and runway guidance - R&D credits are included in the runway guidance, with an expectation of about $1 million in 2024 based on the 2023 tax year [78] Question: Milestone payments from Qilu - A contractual milestone of $10 million is expected when Qilu initiates a Phase 3 trial, anticipated to start soon [80]