8-K: Lisata Therapeutics Announces Positive Preliminary Data from Phase 2 ASCEND Trial in Pancreatic Cancer

Lisata Therapeutics reports encouraging preliminary data from Cohort A of the Phase 2 ASCEND trial, showing a positive trend in overall survival for certepetide in combination with standard chemotherapy for metastatic pancreatic cancer.

Summary

• Lisata Therapeutics announced preliminary Cohort A data from the Phase 2 ASCEND trial evaluating certepetide with standard-of-care chemotherapy in metastatic pancreatic ductal adenocarcinoma.
• The data, presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, showed a median overall survival (mOS) of 12.68 months for the certepetide treated group, compared to 9.72 months for the placebo treated group.
• While median progression-free survival (mPFS) was similar in both groups at 5.5 months, the certepetide group showed 4 complete responses compared to none in the placebo group.
• Lisata plans to advance certepetide development to Phase 3 in early 2026, based on these results and expectations for even better outcomes in Cohort B.
• Cohort A included 95 patients receiving a single intravenous dose of certepetide 3.2 mg/kg or placebo in combination with standard of care.
• Cohort B included 63 patients receiving two intravenous doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with standard of care.

Sentiment

Score: 7

Explanation: The document presents positive preliminary data, particularly the trend in overall survival and complete responses. However, the lack of significant improvement in PFS and the risks associated with clinical development temper the overall sentiment.

Positives

• The preliminary data from Cohort A of the ASCEND trial shows a positive trend in overall survival.
• The certepetide treated group had a median overall survival of 12.68 months, compared to 9.72 months for the placebo group.
• There were 4 complete responses observed in the certepetide treated group, while the placebo group had none.
• Lisata has existing partnerships that validate certepetide's promise and broad applicability.
• The company projects its capital will fund operations into early 2026.

Negatives

• No significant improvement in median progression-free survival (mPFS) was observed (mPFS of 5.5 months in both groups).
• The ASCEND trial's academic design overlooks global regulatory standards supporting eventual approval.

Risks

• The ASCEND trial's academic design overlooks global regulatory standards supporting eventual approval.
• The company's future success depends on the safety and efficacy of its product candidates and regulatory approvals.
• Lisata's ability to finance its operations and the timing of future milestone and licensing fees are subject to uncertainty.
• Rapid technological change in Lisata's markets could impact its ability to successfully develop and commercialize drug candidates.

Future Outlook

Lisata plans to advance certepetide development to Phase 3 in early 2026 and expects to announce numerous milestones over the next 1.5 years. The company believes its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials.

Management Comments

• The data from Cohort A are as we expected and corroborate our decision to add Cohort B to the ASCEND protocol, stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata.
• The increase in overall survival and the observation of 4 complete responses in the certepetide-treated group compared to none in the placebo group for Cohort A, coupled with our expectation of even better outcomes in Cohort B, where we believe early indications show a strong separation in mPFS benefiting patients treated with certepetide, support our plans to advance certepetide development to Phase 3 in early 2026.

Industry Context

Pancreatic cancer remains a significant unmet medical need, and Lisata's approach to enhance the efficacy of existing therapies could be a valuable contribution. The company's focus on solid tumors and its platform technology could position it well in the competitive landscape.

Comparison to Industry Standards

• The median overall survival (mOS) of 12.68 months in the certepetide arm of the ASCEND trial is being compared to the recently FDA-approved NALIRIFOX triplet therapy.
• The company is drawing comparisons to the NAPOLI-3 trial, which evaluated a different treatment regimen for metastatic pancreatic cancer.
• Certepetide's ability to improve overall survival in metastatic PDAC is being compared to the results of the Von Hoff 2013 Phase 3 trial, which established gemcitabine + nab-paclitaxel as standard of care in mPDAC.

Stakeholder Impact

• Positive results could lead to improved treatment options for patients with metastatic pancreatic cancer.
• Successful development and commercialization of certepetide could benefit shareholders through increased company value.
• Positive trial results may enhance Lisata's reputation and attract further partnerships and investment.

Next Steps

• Lisata plans to present Cohort A data at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
• The company expects data from Cohort B in the coming months, with full data from both cohorts to be reported thereafter.
• Lisata plans to advance certepetide development to Phase 3 in early 2026.
• The company will continue to enroll patients in ongoing clinical trials, including the BOLSTER trial in cholangiocarcinoma and the FORTIFIDE trial in pancreatic cancer.

Key Dates