Lisata Therapeutics(US:LSTA)2025-11-06 22:30Financial Data and Key Metrics Changes - For Q3 2025, operating expenses totaled $4.4 million, a decrease of $0.9 million or 17.3% compared to $5.3 million in Q3 2024 [6] - Research and development expenses were approximately $2 million, down from $2.5 million in Q3 2024, representing a decrease of $0.6 million or 22.9% [7] - General and administrative expenses were approximately $2.5 million, compared to $2.8 million in Q3 2024, a decrease of $0.3 million or 12.1% [8] - Net losses for Q3 2025 were $4.2 million, compared to $4.9 million in Q3 2024 [8] - As of September 30, 2025, cash and cash equivalents were approximately $19 million, projected to support operations into Q1 2027 [9] Business Line Data and Key Metrics Changes - The company achieved several development milestones for sirtepotide, including positive preliminary results from multiple studies [4] - A strategic alliance was formed with GATC Health to utilize their AI Drug Discovery Platform for identifying product candidates [5] Market Data and Key Metrics Changes - The ASCEND trial, a phase 2b study, is evaluating sirtepotide in combination with standard chemotherapy for metastatic pancreatic cancer, with preliminary data showing a positive trend in overall survival [11][13] - The Bolster trial, a phase 2a study, completed enrollment ahead of schedule, with top-line data expected in Q4 2025 [16] - The Sendafox trial, a phase 1b/2a study, showed promising early survival data, including a 60% two-year overall survival rate in pancreatic cancer patients [18] Company Strategy and Development Direction - The company is focused on expanding its development pipeline for sirtepotide across various cancer types and exploring non-oncology applications [24] - A new patent for sirtepotide was issued, extending protection until March 2040, covering its chemical structures and applications [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging macro environment affecting small-cap biotech companies, impacting stock performance despite positive clinical results [28] - The company is actively seeking partnerships to fund future phase 3 trials, emphasizing the need for collaboration to minimize shareholder dilution [35] Other Important Information - The company has secured multiple special designations from the U.S. FDA and EMA for sirtepotide [10] - The iLISTA trial, evaluating sirtepotide in combination with immunotherapy, has completed enrollment, with final data expected in Q1 2026 [21][22] Q&A Session Summary Question: When should we expect the next phase 2b data cut for Sendafox? - The timeline is under the control of the investigator, and a precise estimate cannot be provided [26] Question: Can you provide an update on the GBM trial enrollment status? - Enrollment is approximately two-thirds complete, targeting 30 patients [27] Question: What does the cash flow runway to Q1 2027 include? - It covers all operating expenses and costs to support ongoing clinical trials, but does not include assumptions for a phase 3 trial for Sendafox [27] Question: Why has the stock not reacted positively to recent clinical data? - The company attributes this to a combination of negative market forces affecting small-cap biotech and limited trading activity among shareholders [28] Question: Is there a plan to pursue additional licensing opportunities? - The company is actively pursuing new licensing opportunities internally, leveraging existing partnerships [30] Question: What are the next steps following the final analysis of the Sendafox data? - The company plans to seek partners to help fund the phase 3 trial, as raising capital independently would be challenging in the current environment [34]