Release Date: August 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 significant decrease in operating expenses, down 19.7% year-over-year.
- The company has a strong cash position with $38.3 million in cash, cash equivalents, and marketable securities, projected to fund operations into early 2026.
- Certepetide, the company's investigational product, has shown promising pre-clinical and early clinical data, supporting its potential in treating advanced solid tumors.
- The ASCEND trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) has completed enrollment, with top-line data expected in Q4 2024.
- Lisata Therapeutics Inc (LSTA) has received multiple special regulatory designations for Certepetide, including Fast Track and Orphan Drug designations, which could expedite its approval process.
Negative Points
- Overall net losses increased to $5 million for Q2 2024, compared to $4 million in Q2 2023.
- The benefit from income taxes was $0 for Q2 2024, compared to $2.3 million in Q2 2023.
- Enrollment and data readouts for several clinical trials are subject to delays and uncertainties, particularly for investigator-initiated trials.
- The company's reliance on external funding and partnerships for certain trials could pose risks if funding or collaborations do not materialize as expected.
- Lisata Therapeutics Inc (LSTA) faces significant competition and challenges in the oncology space, particularly in the development and commercialization of new cancer therapies.
Q & A Highlights
Q: What kind of feedback did you get from clinicians regarding the rapid enrollment in the cholangiocarcinoma trial?
A: The feedback was overwhelmingly positive, with clinicians expressing enthusiasm about the potential of Certepetide. They speculated that the product was having a positive effect, noting atypical responses in patients. This enthusiasm led to the decision to open a second arm for second-line cholangiocarcinoma due to the high demand and need. β David Mazzo, CEO
Q: What would be the standard of care for cholangiocarcinoma if the trial wasn't running?
A: The first-line treatment for cholangiocarcinoma is gemcitabine, cisplatin, and durvalumab. The trial was designed to include this standard of care, adding Certepetide to it. Patients with this disease typically have a median overall survival of 11 months in the first line and 4-6 months in the second line. β Kristen Buck, EVP of Research & Development, CMO
Q: How much insight do you have into the progress of Qilu Pharmaceutical's Phase 2 trial in mPDAC?
A: Qilu Pharmaceutical, being a private company, does not disclose detailed progress updates. They have informed us that the Phase 2 trial initiated in the second quarter and projected an 18-month enrollment period. We expect to receive general updates during our quarterly joint steering committee meetings. β David Mazzo, CEO
Q: Are there any updates on the enrollment for the Certepetide trial in GBM?
A: Currently, there are no new updates. The trial is running in Estonia, and the lead investigator has been on vacation. We hope to have an update on enrollment in our next call. β David Mazzo, CEO
Q: Do you have an estimate of the pediatric patient population for pancreatic cancer?
A: The pediatric population for pancreatic cancer is nearly zero, as it is not a disease typically found in children. β David Mazzo, CEO
Q: Are there ongoing conversations with other companies about combining Certepetide with their drugs in clinical trials?
A: Yes, we have ongoing dialogues with several companies studying their products for pancreatic cancer and other solid tumors. We are exploring collaborations that could benefit both Certepetide and their investigational drugs. β David Mazzo, CEO
Q: Can you provide an overview of Lisata's intellectual property portfolio?
A: Our IP portfolio covers Certepetide from composition of matter to method of use and indication, protecting the product into the 2030s. We have applications that could extend this into the early 2040s. Additionally, we could benefit from patent term extensions and market exclusivity from orphan designations. β David Mazzo, CEO
Q: What is the current financial status and cash runway for Lisata?
A: As of June 30, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $38.3 million. The company believes this will fund its operations into early 2026, covering anticipated data milestones from ongoing and planned clinical trials. β James Nisco, SVP of Finance and Treasury, Chief Accounting Officer
Q: What are the strategic design choices for Lisata's clinical trials?
A: Our trials are rigorously designed to generate clinically meaningful data, often placebo-controlled and appropriately sized. We aim to fit current treatment practices and regulatory preferences, even if it means higher costs. This approach ensures scientifically rigorous and efficient data generation. β Kristen Buck, EVP of Research & Development, CMO
Q: What are the upcoming milestones for Lisata's clinical trials?
A: Key milestones include top-line data from the ASCEND trial in Q4 2024, complete data by mid-2025, and accelerated enrollment and data readouts from the BOLSTER trial. We also anticipate updates from various global trials evaluating Certepetide in combination with different anti-cancer therapies. β Kristen Buck, EVP of Research & Development, CMO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
