8-K: Lisata Therapeutics Reports Encouraging Q1 2025 Results, Cash Runway Extends Into Q3 2026

Lisata Therapeutics announced its Q1 2025 financial results and provided a business update, highlighting encouraging clinical trial data and a cash runway extending into the third quarter of 2026.

Summary

• Lisata Therapeutics reported its financial results for the first quarter ended March 31, 2025.
• The company's cash runway is projected to extend into the third quarter of 2026.
• Positive results from Cohort A of the ASCEND trial were presented at ASCO-GI 2025.
• Results from Cohort B of the ASCEND trial have been accepted for an oral presentation at ESMO-GI 2025.
• Operating expenses for the quarter were $5.8 million, compared to $6.6 million in the same period last year.
• Research and development expenses were $2.6 million, down from $3.2 million year-over-year.
• General and administrative expenses were $3.2 million, a slight decrease from $3.4 million in the prior year.
• The net loss for the quarter was $4.7 million, compared to $5.4 million for the three months ended March 31, 2024.
• As of March 31, 2025, Lisata had $25.8 million in cash, cash equivalents, and marketable securities.

Sentiment

Score: 7

Explanation: The document presents a mixed sentiment. There are positive aspects such as the extended cash runway, encouraging clinical trial data, and decreased operating expenses. However, there are also negative aspects such as the lack of statistically significant improvement in progression-free survival in the ASCEND trial and the net loss for the quarter. Overall, the sentiment is cautiously optimistic.

Positives

• The company's cash runway extends into the third quarter of 2026, providing financial stability.
• Positive trends in overall survival were observed in the ASCEND trial's Cohort A, with complete responses in the certepetide-treated group.
• The company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025.
• Operating expenses decreased by 11.4% to $5.8 million for the quarter.
• Net losses decreased from $5.4 million to $4.7 million year over year.

Negatives

• The ASCEND Phase 2b preliminary results showed no statistically significant improvement in progression-free survival with certepetide.
• The company reported a net loss of $4.7 million for the first quarter of 2025.
• The initiation of the FORTIFIDE study remains on hold.

Risks

• The company's clinical trials may not yield positive results.
• Regulatory approvals for certepetide are not guaranteed.
• The company may face challenges in financing its operations.
• The company's reliance on partnerships carries risks associated with partner performance.
• The Priority Review Voucher program expires September 2026 and may not be renewed.

Future Outlook

Lisata expects a data-rich period for the remainder of 2025 and into 2026, with anticipated results from Cohort B of the ASCEND trial and Catalent's preclinical evaluation.

Management Comments

• Lisata maintains momentum into 2025 despite a challenging market for small cap healthcare companies as we continue to make notable progress in both our clinical development portfolio and partnering initiatives, stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata.
• Overall, our focus remains on evaluating certepetide in multiple clinical and preclinical studies across a variety of solid tumors and non-cancer indications.
• Based on concentrated efforts to manage our finances prudently, we now project having operational cash into the third quarter of 2026 as we finalize next steps in certepetide development, based on upcoming conversations with various regulatory agencies including the FDA, TGA and EMA.

Industry Context

Lisata is operating in a challenging market for small-cap healthcare companies, but is focused on developing innovative therapies for solid tumors, an area with significant unmet need.

Comparison to Industry Standards

• The company's approach to enhancing the effectiveness of existing anti-cancer therapies aligns with the industry's focus on combination therapies and targeted drug delivery.
• The ASCEND trial is evaluating certepetide in combination with gemcitabine/nab-paclitaxel, a standard-of-care chemotherapy regimen for pancreatic cancer.
• The company's research collaborations with Valo Therapeutics and Catalent are consistent with the industry trend of partnering to leverage complementary technologies and expertise.
• The company's cash runway extending into Q3 2026 is a positive sign, as many small biotech companies struggle to maintain sufficient funding for their clinical programs.
• The company is pursuing rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-ofcare (SoC).
• The company is demonstrating certepetide effectiveness when combined with a variety of other SoC regimens (e.g., chemotherapy, immunotherapy, etc.) in a variety of solid tumors.

Stakeholder Impact

• Shareholders may be encouraged by the extended cash runway and positive clinical trial data.
• Employees may be reassured by the company's financial stability.
• Patients may benefit from the development of new therapies for solid tumors.
• Partners may be encouraged by the company's progress in clinical development.

Next Steps

• The company plans to finalize next steps in certepetide development based on upcoming conversations with regulatory agencies.
• The company anticipates data from Cohort B of the ASCEND trial in the coming months.
• The company expects data from Catalent's preclinical evaluation combining certepetide with their SMARTag ADC platform.
• The company is preparing for a Phase 3 trial.
• The company will continue to enroll patients in ongoing clinical trials.

Key Dates

Keywords

certepetide, Lisata Therapeutics, clinical trials, ASCEND trial, pancreatic cancer, financial results, oncology, tumor, cancer