Lisata Therapeutics(US:LSTA)2024-08-13 04:20Financial Data and Key Metrics Changes - Operating expenses for Q2 2024 totaled $5.5 million, a decrease of $1.4 million or 19.7% compared to $6.9 million in Q2 2023 [5][6] - Research and development expenses were approximately $2.6 million, down from $3.2 million in Q2 2023, representing a decrease of $0.6 million or 17.7% [6] - General and administrative expenses were approximately $2.9 million, a decrease of $0.8 million or 21.3% compared to $3.7 million in Q2 2023 [7] - Net losses were $5 million for Q2 2024, compared to $4 million for Q2 2023 [8] - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities of approximately $38.3 million, expected to fund operations into early 2026 [8] Business Line Data and Key Metrics Changes - The company is focused on advancing its development pipeline centered around Certepetide for treating advanced solid tumors [4][5] - The ASCEND trial is a key study evaluating Certepetide in combination with standard chemotherapy for metastatic pancreatic cancer, with top-line data expected in Q4 2024 [22][23] Market Data and Key Metrics Changes - The company is pursuing multiple special regulatory designations for Certepetide, including fast track and orphan drug designations, which enhance its market position [17][18] Company Strategy and Development Direction - The company aims to optimize Certepetide's regulatory review and future commercialization through strategic design choices in clinical trials [10][20] - The development strategy includes rapid registration for pancreatic cancer and exploring partnerships to maximize the product's value [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Certepetide's potential to transform cancer treatment, with the upcoming ASCEND data readout seen as a critical moment for the company [33] - The company is committed to advancing Certepetide across multiple tumor types and exploring strategic partnerships [33] Other Important Information - Certepetide has shown favorable clinical safety and tolerability, with significant preclinical data supporting its efficacy in enhancing delivery of standard-of-care chemotherapy [16][17] Q&A Session Summary Question: Feedback from clinicians on enrollment and demand for Certepetide - Management received positive feedback from clinicians regarding the rapid enrollment and enthusiasm for Certepetide's potential impact on treatment outcomes [35] Question: Standard-of-care for cholangiocarcinoma - The current standard-of-care for cholangiocarcinoma includes gemcitabine, cisplatin, and durvalumab, with poor overall survival rates for patients [39] Question: Progress on Phase 2 trial in mPDAC - The independent company conducting the trial does not provide regular updates, but management expects to receive insights during quarterly joint steering committee meetings [42] Question: Enrollment updates for GBM trial - Enrollment updates for the GBM trial are pending, with expectations for increased enrollment as sites in Latvia are open [45] Question: Pediatric patient population in pancreatic cancer - The pediatric population for pancreatic cancer is extremely small, essentially close to zero [47] Question: Collaboration with other drug companies - Management confirmed ongoing dialogues with other companies regarding potential collaborations to enhance the efficacy of their products with Certepetide [48][49] Question: Intellectual property status - The company has a broad intellectual property portfolio covering Certepetide, with protections extending into the 2030s and potential extensions into the 2040s [51]