10-Q: Lisata Therapeutics Reports Q1 2025 Financial Results and Provides Business Update

Lisata Therapeutics reports a net loss of $4.724 million for Q1 2025, with a focus on advancing its clinical-stage drug, certepetide, for solid tumor treatment.

Summary

• Lisata Therapeutics, a clinical-stage pharmaceutical company, reported its financial results for the quarter ended March 31, 2025.
• The company is focused on developing certepetide, an investigational drug designed to enhance the penetration of anti-cancer drugs into solid tumors.
• Lisata reported a net loss of $4.724 million for the quarter, compared to a net loss of $5.401 million for the same period in 2024.
• Research and development expenses decreased to $2.602 million from $3.241 million year-over-year, primarily due to reduced clinical research organization (CRO) expenses and lower spending on chemistry, manufacturing, and controls (CMC).
• General and administrative expenses decreased slightly to $3.245 million from $3.360 million year-over-year.
• As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities totaling approximately $25.8 million.
• The company believes its current cash resources are sufficient to fund operations for at least the next 12 months.
• Lisata anticipates needing additional financing in the long term, which may include debt or equity issuances, partnerships, collaborations, or asset sales.
• The initiation of the FORTIFIDE study remains on hold as the Company is investigating a potentially faster and more cost-effective approach to achieving the study objective.
• The Company has similarly decided to delay commencement of certain phase 3 readiness activities for chemistry, manufacturing and controls (CMC).

Sentiment

Score: 5

Explanation: The sentiment is neutral. While the company reduced its net loss compared to the previous year, it still faces financial challenges and relies on future financing. The delay of the FORTIFIDE study and phase 3 readiness activities for chemistry, manufacturing and controls (CMC) is also a negative factor.

Positives

• The net loss decreased from $5.401 million in Q1 2024 to $4.724 million in Q1 2025.
• Research and development expenses decreased, indicating potential cost management.
• The company believes it has sufficient cash to meet funding requirements over the next year.

Negatives

• The company continues to experience net losses.
• The company anticipates needing additional financing in the long term.
• The initiation of the FORTIFIDE study remains on hold.
• The Company has similarly decided to delay commencement of certain phase 3 readiness activities for chemistry, manufacturing and controls (CMC).

Risks

• The company's history of operating losses and liquidity challenges may make it difficult to raise capital on acceptable terms.
• The demand for the equity and debt of pharmaceutical companies is dependent upon many factors, including the general state of the financial markets.
• The company's inability to obtain additional capital could materially and adversely affect its business operations.
• The company's future capital requirements are difficult to forecast and will depend on many factors including the timing and nature of any other strategic transactions that we undertake; and our ability to establish and maintain collaboration partnerships, in-license/out-license or other similar arrangements and the financial terms of such agreements.

Future Outlook

The company believes its cash on hand and marketable securities will enable it to fund current operating expenses for at least the next 12 months, but anticipates needing additional financing in the long term through various means, including potential debt or equity issuances, partnerships, collaborations, or asset sales.

Management Comments

• The company's leadership team has decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development from preclinical through to product registration and launch.
• The Company's goal is to develop and commercialize products that address important unmet medical needs.

Industry Context

Lisata Therapeutics is operating in the competitive pharmaceutical industry, specifically targeting solid tumors with its investigational drug, certepetide; the company faces competition from established pharmaceutical companies and other biotechnology firms developing cancer therapies.

Comparison to Industry Standards

• The Objective Response Rate (ORR) of 59% was observed, compared to the 23% ORR observed in the MPACT clinical trial that served as the basis for approval of the chemotherapy combination nab-paclitaxel and gemcitabine for the treatment of first line mPDAC (Von Hoff, et al. 2013).
• A Disease Control Rate (DCR) (partial and complete responses plus stable disease) of over 79% was also observed in comparison to a DCR of 48% observed in the MPACT trial.
• Reduction in the level of circulating tumor biomarker CA19-9 was observed in 96% of patients versus 61% in the MPACT trial.
• Importantly, median progression-free survival and median overall survival of nearly ten months and over thirteen months were observed versus less than six months and less than nine months, respectively, in the MPACT trial.

Stakeholder Impact

• Shareholders may experience dilution if the company issues additional equity.
• Employees' job security could be affected by the company's financial performance and need for cost management.
• Patients with solid tumors may benefit from the successful development and commercialization of certepetide.
• The company's suppliers and partners may be affected by its financial condition and ability to meet its obligations.

Next Steps

• The company will continue to advance its clinical trials for certepetide in various solid tumor types.
• The company will seek additional financing through various means, including debt or equity issuances, partnerships, collaborations, or asset sales.
• The company will present preliminary data from Cohort B of the ASCEND trial at the ESMO-GI meeting in July 2025.
• The company will continue targeting key governmental agencies and not-for-profit organizations to contribute funds for the Companys research and development programs.

Key Dates

Keywords

certepetide, Lisata Therapeutics, financial results, clinical trials, solid tumors, research and development, net loss, funding, oncology, pharmaceutical