Lisata Q3 2025 Earnings Call Summary and Q&A Highlights: Strategic Alliances and Clinical Progress

Earnings Call11-09

[Management View]
Lisata Therapeutics reported significant progress in clinical and corporate initiatives, including a notable reduction in operating expenses and a strengthened capital position. Key strategic alliances with Catalent and GATC Health, along with an extended patent estate, bolster near-term opportunities for product and platform expansion. Management emphasized a clear regulatory and operational pathway for a Phase III ASCEND trial, contingent on securing additional funding.

[Outlook]
The company projects a financial runway extending into 2027, excluding Phase III ASCEND expenditures. Management is actively seeking strategic partnerships to fund next-phase trials. Several ongoing studies, including ASCEND, IELISTA, and Chilu's metastatic pancreatic cancer study, are expected to yield data by 2026.

[Financial Performance]
Operating expenses decreased by 17.3% YoY to $4.4 million, driven by reduced R&D and administrative spending. Net loss narrowed to $4.2 million from $4.9 million YoY. Cash and cash equivalents stood at $19 million, supporting operations into 2027.

[Q&A Highlights]
Question 1: When should we expect the next data cut for SENDFOX, and what is the enrollment status for the GBM trial?
Answer: The timing of the next data cut for SENDFOX is uncertain as it is controlled by the University of Kansas Cancer Center. For the GBM trial, enrollment is on track, with approximately two-thirds of the 30-patient target achieved.

Question 2: What does the cash flow runway to 2027 include, and is a Phase III ASCEND trial factored in?
Answer: The runway covers all operating expenses and ongoing clinical trials but does not include a Phase III ASCEND trial.

Question 3: Despite robust clinical data, why hasn't the share price reacted as expected?
Answer: The macro environment is unfavorable for small-cap biotech, and many shareholders hold long-term positions, limiting trading activity. The market may be missing the broad applicability of cerdepatide across various cancers.

Question 4: Is there a plan to pursue more licensing agreements given recent positive results?
Answer: Yes, Lisata is actively pursuing additional licensing agreements, leveraging existing nonexclusive licenses to generate interest.

Question 5: What are the next steps following the final ASCEND data analysis, considering the need for substantial funding for Phase III?
Answer: Lisata plans to partner with pharma companies to fund Phase III trials, having prepared internally for this transition by aligning with regulatory requirements and engaging with potential CROs.

[Sentiment Analysis]
Analysts expressed interest in the company's strategic direction and clinical progress. Management maintained a positive tone, emphasizing strategic partnerships and prudent financial management.

[Quarterly Comparison]
| Metric | Q3 2025 | Q3 2024 | Change |
|-------------------------------|---------------|---------------|--------------|
| Operating Expenses | $4.4 million | $5.3 million | -17.3% |
| R&D Expenses | $2 million | $2.5 million | -22.9% |
| General & Administrative | $2.5 million | $2.8 million | -12.1% |
| Net Loss | $4.2 million | $4.9 million | -14.3% |
| Cash and Cash Equivalents | $19 million | N/A | N/A |

[Risks and Concerns]
The primary risk is the need for substantial funding to advance the Phase III ASCEND trial. The current financing environment poses challenges for raising capital without significant shareholder dilution.

[Final Takeaway]
Lisata Therapeutics is making significant strides in clinical development and strategic partnerships, positioning itself for future growth. However, the successful execution of its Phase III ASCEND trial hinges on securing additional funding through strategic partnerships. The company's ability to navigate the current financial landscape and leverage its clinical successes will be crucial in realizing its long-term objectives.
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