Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Lisata Therapeutics Inc (LSTA, Financial) reported a decrease in operating expenses by 10.5% compared to the same period last year, indicating effective cost management.
- The company has a strong cash position with approximately $35.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into early 2026.
- Certepetide has shown promising potential in preclinical and early clinical data as a treatment for advanced solid tumors, including pancreatic and cholangiocarcinoma.
- The ASCEND trial for certepetide in metastatic pancreatic ductal adenocarcinoma has reached a significant milestone with preliminary results to be presented at ASCO GI in January 2025.
- Lisata Therapeutics Inc (LSTA) has received multiple special regulatory designations for certepetide, including orphan drug designation and fast track designation, enhancing its development prospects.
Negative Points
- Despite progress, Lisata Therapeutics Inc (LSTA) is frustrated with its current share price and market valuation, which they believe does not reflect the company's true value.
- The GBM trial has experienced slower than expected enrollment due to delays in site initiation in Latvia.
- General and administrative expenses increased by 8.1% compared to the previous year, primarily due to higher consulting expenses.
- The company faces challenges in patient enrollment for certain trials, particularly in second-line cholangiocarcinoma, due to the poor performance status of patients.
- Lisata Therapeutics Inc (LSTA) acknowledges that its ability to pursue all potential opportunities is limited by available capital.
Q & A Highlights
Q: Can you provide an update on the enrollment progress for the glioblastoma multiforme (GBM) study?
A: Our GBM trial has started slower than expected due to delays in site initiation in Latvia. However, the Estonian site has enrolled five patients, and we anticipate the Latvian sites will be online soon to meet our enrollment expectations. - David Mazzo, CEO
Q: Could you elaborate on the potential of certepetide in treating endometriosis and its mechanism?
A: Endometriosis is a tumor-like disease with upregulated receptors for certepetide's targeting. We aim to stop angiogenesis in endometriosis by combining certepetide with an anti-VEGF agent, addressing a significant unmet medical need. - Kristen Buck, EVP of R&D, CMO
Q: How is patient enrollment progressing in your major trials compared to typical expectations?
A: The ASCEND trial enrolled 158 patients over 1.5 years, which is a good rate. The BOLSTER trial's first-line cohort recruited six months ahead of schedule, while the second-line cohort is progressing as expected. - David Mazzo, CEO and Kristen Buck, EVP of R&D, CMO
Q: How do you prioritize opportunities for certepetide collaborations, such as with ValoTx?
A: We prioritize based on unmet medical needs, trial duration, and potential for complementary mechanisms. We also consider collaborations where partners cover costs, allowing us to focus on trials that yield data within our funding window. - David Mazzo, CEO
Q: What level of detail should we expect in the ASCEND trial's Cohort A data readout?
A: Expect to see progression-free survival, median progression-free survival, median overall survival, and response rates. Overall survival and complete response numbers will be crucial for determining next steps. - David Mazzo, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
