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Lisata Therapeutics(LSTA) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Financial Data and Key Metrics Changes - Operating expenses for Q1 2025 totaled $5.8 million, a decrease of $800,000 or 11.4% compared to $6.6 million in Q1 2024 [8] - Research and development expenses were approximately $2.6 million for Q1 2025, down from $3.2 million in Q1 2024, representing a decrease of $600,000 or 19.7% [9] - General and administrative expenses were about $3.2 million for Q1 2025, compared to $3.4 million in Q1 2024, a decrease of approximately $100,000 or 3.4% [9] - Net losses were $4.7 million for Q1 2025, compared to $5.4 million for Q1 2024 [9] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of approximately $25.8 million, expected to support operations into Q3 2026 [10] Business Line Data and Key Metrics Changes - The company is focused on the development of cerdepatide for advanced solid tumors and other difficult-to-treat diseases, with ongoing clinical trials showing promising preliminary results [6][11] - The ASCEND trial is evaluating cerdepatide in combination with standard care for metastatic pancreatic ductal adenocarcinoma, with preliminary results indicating a positive trend in overall survival [15] - The BOLTAR trial for cholangiocarcinoma has completed enrollment ahead of schedule, with a second cohort added for second-line treatment [16] Market Data and Key Metrics Changes - The company continues to face persistent market headwinds for small-cap healthcare companies but maintains strong momentum into 2025 [5] - The ASCEND trial data presented at the ASCO GI symposium reinforced the potential of cerdepatide and the overall development strategy [6] Company Strategy and Development Direction - The company aims to advance cerdepatide as a cornerstone treatment for advanced solid tumors, with several key milestones anticipated in the next 12 to 18 months [7] - Collaborations with other companies, such as Qilu Pharmaceutical and AstraZeneca, are being pursued to enhance the development of cerdepatide [18][22] - The company is exploring additional opportunities to advance its development strategy, including progressing cerdepatide into a global Phase III trial for pancreatic cancer [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of cerdepatide for patients and significant long-term value for shareholders [26] - The company is focused on prudent capital management and expense minimization while advancing its R&D activities [9][10] Other Important Information - The company has secured multiple special designations from both the FDA and EMA for cerdepatide, enhancing its regulatory position [12] - The company is actively exploring new strategic development opportunities across oncology and other therapeutic areas [22] Q&A Session Summary Question: Impact of capped enrollment in the BOLTAR trial on regulatory path - Management clarified that the BOLTAR trial is not powered to any specific endpoint, and the reduced enrollment will still allow for meaningful data analysis [30] Question: Depth of data analysis for ASCEND presentation - Management indicated that preliminary data will be presented, with definitive data expected at the ESMO GI conference in July [35] Question: Timeline for data from Qilu Pharmaceutical's study - Management noted that they have no control over Qilu's timelines but emphasized the importance of obtaining approval in China before other markets [39] Question: Potential partnerships in endometriosis field - Management stated that discussions are in early stages, with most potential partners currently focused on clinically ready assets [51] Question: Manufacturing capabilities for clinical trials - Management explained that big pharma typically does not function as contract manufacturers for other products unless they have signed deals [43]