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]

Lisata Therapeutics (LSTA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Welcome to the Losada Therapeutics First Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, participants are in listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, 05/08/2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications ...