8-K: Lisata Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update

Lisata Therapeutics highlights promising preliminary Phase 2b pancreatic cancer data, completes enrollment in a Qilu Phase 2 trial, advances its development portfolio, and extends its cash runway into the second quarter of 2026.

Summary

• Lisata Therapeutics reported its full-year 2024 financial results and provided a business update.
• The company is advancing its development portfolio centered around certepetide.
• Preliminary Phase 2b (ASCEND) pancreatic cancer data (Cohort A) showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group.
• Data from Cohort B is expected in the coming months.
• Enrollment has been completed in the Qilu Phase 2 trial evaluating certepetide for first-line mPDAC.
• Lisata anticipates multiple milestones over the next 12+ months.
• The company's cash runway extends into the second quarter of 2026.
• Revenue for the year ended December 31, 2024, totaled $1.0 million due to a license fee from Kuva Labs.
• Operating expenses for 2024 were $23.4 million, a decrease from $25.7 million in 2023.
• Research and development expenses decreased to $11.3 million from $12.7 million.
• General and administrative expenses decreased to $12.1 million from $13.0 million.
• The net loss for 2024 was $20.0 million, compared to $20.8 million in 2023.
• As of December 31, 2024, Lisata had $31.2 million in cash, cash equivalents, and marketable securities.
• Lisata received $0.9 million in non-dilutive funding from the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program.
• The company has sold $19.6 million in tax benefits for net proceeds of $18.4 million under the program to date.

Sentiment

Score: 7

Explanation: The document presents a mixed sentiment. Positive aspects include promising clinical trial data, a collaboration agreement, and a cash runway extending into 2026. However, there are also negative aspects such as a net loss and a decrease in cash reserves.

Positives

• Preliminary Phase 2b (ASCEND) pancreatic cancer data (Cohort A) showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group.
• Enrollment has been completed in the Qilu Phase 2 trial evaluating certepetide for first-line mPDAC.
• Lisata's cash runway extends into the second quarter of 2026.
• The company received $1.0 million in revenue from a license fee with Kuva Labs.
• Operating expenses decreased by $2.3 million compared to the previous year.
• Lisata received $0.9 million in non-dilutive funding from the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program.

Negatives

• The company reported a net loss of $20.0 million for the year ended December 31, 2024.
• Cash, cash equivalents, and marketable securities decreased from $50.5 million in 2023 to $31.2 million in 2024.

Risks

• The timing of Cohort B data from the ASCEND trial is dependent on accumulating the requisite number of endpoint events and cannot be accurately predicted.
• The exact timing of CENDIFOX data is not in Lisata's control as it is an investigator-initiated study.
• The Priority Review Voucher program expires in September 2026 and may not be renewed.

Future Outlook

Lisata expects 2025 to be a data-rich year and anticipates multiple milestones over the next 12-18 months. The company believes its projected capital will fund operations into the second quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials.

Management Comments

• Throughout 2024 and now into early 2025, we continue to advance our development portfolio centered around our novel product candidate, certepetide, stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata.
• Following the encouraging preliminary results from the ASCEND and iLSTA trials reported at this years ASCO-GI Symposium, we remain committed to exploring the broad application of certepetides unique mechanism of action.
• For Lisata, we expect 2025 to be a data-rich year and we look forward to sharing key developments as they become available.

Industry Context

Lisata Therapeutics is focused on improving solid tumor treatment, which remains a significant global need, with solid tumors accounting for over 90% of diagnosed cancers. The company's approach addresses the challenges posed by tumor morphology and the tumor microenvironment, which often limit the effectiveness of current treatments.

Comparison to Industry Standards

• The company compares the overall survival results of certepetide plus SoC chemotherapy in metastatic PDAC from two Phase 1 clinical trials to the recently FDA-approved NALIRIFOX triplet therapy.
• The ASCEND trial is compared to the NAPOLI-3 trial, noting a similar separation in overall survival curves at 7 months.
• Certepetide's ability to potentiate a complete response in metastatic gastroesophageal adenocarcinoma (mGEAC) is highlighted as remarkable evidence of activity in other solid tumors.

Stakeholder Impact

• Shareholders: The update provides information on the company's financial performance and clinical development programs, which could influence investment decisions.
• Employees: The announcement of continued funding and advancement of clinical programs suggests job security and potential growth opportunities.
• Patients: Positive clinical trial results offer hope for improved treatment options for advanced solid tumors.
• Partners: The update provides information on the progress of collaborations and potential future opportunities.

Next Steps

• Lisata expects to announce numerous milestones over the next 1.5 years.
• The company plans to prepare for a Phase 3 trial.
• The company plans to prepare a provisional approval application (TGA).

Key Dates