Lisata (LSTA) Q3 2025 Earnings Call Transcript

CALL PARTICIPANTS

• President and Chief Executive Officer — Dr. David J. Mazzo
• Executive Vice President of Research and Development and Chief Medical Officer — Dr. Kristen K. Buck
• Senior Vice President of Finance and Treasury and Chief Accounting Officer — James Nisco

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TAKEAWAYS

• Operating Expenses — $4.4 million, down $900,000 or 17.3% compared to $5.3 million for the same period in the prior year, due primarily to reduced R&D and general administrative spending.
• Research and Development Expenses — $2 million, a $600,000 or 22.9% decrease from $2.5 million in the comparable quarter, attributed to lower chemistry, manufacturing, and controls costs and reduced clinical department spend, partially offset by increased BOLTAR trial costs due to a prior year CRO refund.
• General and Administrative Expenses — $2.5 million, a decrease of $300,000 or 12.1% from $2.8 million for the same quarter last year, mainly due to lower consulting costs and elimination of a position.
• Net Loss — $4.2 million, reduced from $4.9 million for the corresponding period last year.
• Cash and Cash Equivalents — $19 million as of quarter-end, with management projecting a runway into 2027 for current operations and clinical activities, excluding expenditure for a Phase III ASCEND trial.
• ASCEND Trial Development — Preliminary Cohort B data exhibited a positive trend in progression-free survival, overall survival, and objective response rate for cerdepatide plus standard of care compared to placebo; a complete response was observed only in the treatment group.
• ASCEND Safety — Pooled analysis from both cohorts A and B indicated “no increased adverse events in the cerdepatide plus standard of care treated group beyond those experienced in the standard of care plus placebo-treated groups.”
• ASCEND Regulatory Progress — A completed end-of-Phase II meeting with FDA led to agreement on “the fundamental aspects of an acceptable global Phase III protocol including dose and dosing regimen, blinding, and primary endpoints.” Management confirmed readiness for Phase III subject to available capital.
• BOLTAR Trial Update — Enrollment for the first-line cholangiocarcinoma arm finished nearly six months ahead of plan; total enrollment in the second-line cohort was capped at 20 patients for efficiency, with this exploratory arm not statistically powered.
• SENDFOX Trial Data — Preliminary results in the pancreatic cancer cohort showed a 50% R0 resection rate and a 70% pathological partial response among patients completing therapy, with a reported 60% two-year overall survival rate.
• IELISTA Trial Status — Enrollment is complete, and interim analysis revealed “compelling positive preliminary data” for cerdepatide in combination with immunotherapy, with final outcomes expected in 2026.
• GBM Trial Progress — Enrollment is approximately two-thirds complete toward the 30-patient target, proceeding on schedule.
• Chilu Licensee Update — Development partner Chilu completed patient enrollment (90 subjects) in metastatic pancreatic cancer; initial data is anticipated in the next 12 to 18 months.
• Catalent Licensing Agreement — A nonexclusive global license was granted to Catalent (NYSE:CTLT) for use of cerdepatide and its analogs as payloads for the SmartTag ADC platform; Catalent’s preclinical results demonstrated enhanced tumor-selective penetration and efficacy.
• Strategic Alliance with GATC Health — Entered a collaboration to leverage AI-powered drug discovery for new indications and novel compounds, with several candidates targeted for clinical development in 2026.
• Patent Extension — The U.S. Patent and Trademark Office issued a new composition of matter patent for cerdepatide in July 2025, providing protection through March 2040 with potential extensibility.

SUMMARY

Lisata Therapeutics (NASDAQ:LSTA) reported material progress in both clinical and corporate initiatives, including a pronounced reduction in operating expenditures and strengthened capital position. Management advanced multiple cerdepatide clinical programs with new trial data indicating clinical benefit and maintained positive safety profiles across diverse oncology indications. Strategic alliances with Catalent and GATC Health, as well as an extended patent estate, reinforce near-term opportunities for product, platform, and non-dilutive capital expansion. The company articulated a clear regulatory and operational pathway for a Phase III ASCEND trial, though noted this is contingent on securing additional funding, with management actively seeking partnering solutions.

• The financial runway extends into 2027, but no Phase III ASCEND expenditures are included in this projection, as acknowledged by management.
• Management said, “The original trial was designed with an academic bench rather than one with commercial and regulatory objectives and was statistically powered based on a six-month progression-free survival primary endpoint. This endpoint is unusual in that it has not been previously used as the basis of approval for an anticancer drug.”
• Lisata’s leadership emphasized direct engagement with potential licensing partners, citing recent Catalent and Chilu agreements as cornerstones for continued business development efforts.
• Dr. Mazzo clarified that “in this current financing environment, it’s going to be next to impossible to raise the amount of money necessary to unilaterally fund that phase three in a manner that would not be so overly dilutive to current shareholders,” underscoring reliance on strategic investment or partnering to execute next-phase trials.
• Several ongoing and near-readout investigator-initiated studies may introduce future variability in timelines, with final ASCEND, IELISTA, and Chilu metastatic pancreatic cancer study data all targeted for 2026 or beyond.

INDUSTRY GLOSSARY

• CD34+ cell therapy: A regenerative treatment utilizing hematopoietic stem cells expressing the CD34 marker, aimed at tissue repair and disease reversal.
• CRO (Contract Research Organization): An external service provider managing clinical trial operations, data management, and protocol execution.
• R0 resection: Surgical removal of a tumor with negative margins, indicating no microscopic residual cancer at the cut edge.
• RECIST (Response Evaluation Criteria in Solid Tumors): A standardized measurement framework for tumor response in clinical trials, based on changes in tumor size.
• SmartTag ADC (Antibody-Drug Conjugate): Catalent’s targeted drug platform enabling tissue-selective delivery of cytotoxic agents via engineered antibodies tagged with customizable payloads.
• PD-1/PD-L1: Immune checkpoint proteins targeted by immunotherapies to enhance anti-tumor immune responses.

Full Conference Call Transcript

Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer; and James Nisco, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our third quarter 2025 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received the news release or if you would like to be added to the company’s email distribution list, please subscribe to the email alerts on the company website or email me at [email protected] to be added. Sorry.

Before we begin, I remind you that comments made by management during this conference call contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata Therapeutics. I encourage you to review the company’s filings with the Securities and Exchange Commission, including without limitation, its Forms 10-Q, 8-Ks, and 10-Ks, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, November 6, 2025.

Lisata Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, I will now turn the call over to Dr. David Mazzo. Dave?

David Mazzo: Thank you, John, and good afternoon, everyone. It’s my pleasure to provide the latest update of Lisata Therapeutics’ recent business highlights, discuss our third quarter 2025 financial results, and give a report on the progress of our development programs. Building on the momentum from the first half of the year, Lisata Therapeutics achieved several development milestones involving cerdepatide, including the announcement of encouraging preliminary results from multiple studies including the ASCEND trial, the IELISTA trial, and the SENDFOX trial, adding further corroboration to our expectations of the positive impact of cerdepatide as part of various anticancer treatment regimens.

On the business development front, we entered into a strategic alliance with GATC Health to use their multinomial Advanced Technology Artificial Intelligence Drug Discovery platform to identify product candidates for development. We also executed a nonexclusive global license agreement with Catalent in which Catalent gains access to cerdepatide and its analogs for use as a payload for their SmartTag ADC technology platform. We continue to anticipate that the next several quarters will be a data and transaction-rich period for Lisata Therapeutics with several key milestones on the horizon. Following the review of our financial results, Dr.

Kristen Buck, our Chief Medical Officer and Head of R&D, will provide an update on our ongoing and planned clinical studies, including timelines and key achievements. With that, I will now turn the call over to James Nisco, Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?

James Nisco: Thanks, Dave. Good afternoon, I’m pleased to join you today to present a summary of our third quarter 2025 financial results. Next, a review of our operating expenses. For the three months ended September 30, 2025, operating expenses totaled $4.4 million compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $900,000 or 17.3%. Research and development expenses were approximately $2 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $600,000 or 22.9%.

This was primarily due to lower spend on chemistry, manufacturing and controls, and a reduction in clinical department expenses, partially offset by an increase in the bolster trial costs as a result of a CRO refund in the prior year quarter related to trial protocol modifications. On a year-over-year comparison, for the nine months ended September 30, 2025, bolster trial costs are lower than the prior year. General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $300,000 or 12.1%. This was primarily due to lower spend on consulting and savings from the elimination of an employee position.

Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024. It is noteworthy that we continue to make progress according to our plans for our R&D and business activities while continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of September 30, 2025, we had cash and cash equivalents of approximately $19 million. Based on our existing and planned activities, the company projects that available funds will support current operations into 2027.

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