LISATA THERAPEUTICS, INC. Q2 FY2024 earnings call

• Lisata maintained momentum in the development of Certepetide, a novel investigational product for advanced solid tumors, leveraging the CendR Platform to target tumor stroma and microenvironment.
• Ongoing clinical trials include the ASCEND trial (metastatic pancreatic cancer), BOLSTER trial (first-line cholangiocarcinoma), CENDIFOX trial (pancreatic/colon/appendiceal cancers), and others globally.
• Regulatory designations such as fast track, orphan drug, and rare pediatric disease designations enhance the potential for accelerated approvals and market exclusivity.
• Clinical studies are designed with scientific rigor, including placebo-controlled, appropriately sized trials to generate clinically meaningful data.

For the three months ended June 30, 2024, operating expenses totaled $5.5 million, a decrease of $1.4 million (19.7%) compared to the same period in 2023. Research and development expenses were $2.6 million in Q2 2024, down $0.6 million (17.7%) from Q2 2023, primarily due to reduced Phase 2b ASCEND trial expenses and lower CMC-related and equity expenses, partially offset by increased BOLSTER trial enrollment costs. General and administrative expenses were $2.9 million in Q2 2024, a decrease of $0.8 million (21.3%) from Q2 2023, driven by lower severance, equity, and insurance costs. Net losses were $5 million in Q2 2024, up from $4 million in Q2 2023. As of June 30, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $38.3 million, with projected capital funding operations into early 2026.

• Anticipated top line data from the ASCEND trial Cohort A in Q4 2024 and complete data set by mid-2025.
• Committed to advancing Certepetide across multiple tumor types and exploring strategic partnerships to maximize its value.
• Expect to provide further updates on trial progress throughout the year.

• Clinical trial timelines and enrollment may be affected by investigator availability, funding, or regulatory delays.
• Uncertainty around regulatory approval processes and maintaining market exclusivity.
• Dependence on third-party companies (e.g., Qilu Pharmaceutical) for some trials, with limited control over their progress.

Q: Steve Brozak asked about feedback from clinicians on rapid enrollment in the first-line cholangiocarcinoma trial and second-line expansion.

A: David Mazzo stated clinicians were enthusiastic about Certepetide's potential, with feedback indicating atypical patient responses suggesting positive effects.

Q: Sara Nik inquired about Qilu Pharmaceutical's Phase 2 mPDAC trial progress.

A: David Mazzo noted Qilu is private and doesn't disclose trial details, but they're on track for 18 months of enrollment.

Q: Will Hidell asked about GBM trial enrollment.

A: David Mazzo said enrollment is ongoing, with investigator leads on vacation, but expected updates in future calls.

Q: Peter Enderlin asked about intellectual property and collaborations.

A: David Mazzo said Lisata has a broad IP portfolio protecting Certepetide into the 2030s, and ongoing collaborations with other companies to explore Certepetide combinations.

Q: Robert Sassoon asked about intellectual property.

A: David Mazzo detailed the IP portfolio covering composition, method of use, indications, and formulations, protecting into the 2030s with potential extensions.