Lisata Therapeutics, Inc. (LSTA) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reflects a mixed sentiment. While there are positive developments like reduced losses and strategic collaborations, significant risks remain. The company's reliance on Certepetide and the need for capital for Phase III trials are concerning. The Q&A section did not alleviate these concerns, particularly with management's unclear responses on regulatory challenges. The decrease in expenses and positive cash position are offset by the limited revenue and pipeline risks. Without clear positive catalysts or guidance, the stock is likely to remain stable, resulting in a neutral sentiment.
Key Financial Performance
Revenue For the 3 months ended June 30, 2025, revenue totaled $70,000 in connection with an upfront license fee related to a research license agreement with Catalent, Inc. There was no revenue for the 3 months ended June 30, 2024.
Operating Expenses For the 3 months ended June 30, 2025, operating expenses totaled $4.9 million compared to $5.5 million for the 3 months ended June 30, 2024, representing a decrease of $0.6 million or 10.6%. This decrease was due to reductions in patient treatment costs, clinical research organization expenses, and lower spend on consulting, travel, and entertainment expenses.
Research and Development Expenses Research and development expenses were approximately $2.3 million for the 3 months ended June 30, 2025, compared to $2.6 million for the 3 months ended June 30, 2024, representing a decrease of $0.3 million or 13.4%. This was primarily due to a reduction in patient treatment costs and clinical research organization expenses associated with the Phase IIa BOLSTER trial and lower spend on chemistry, manufacturing, and controls.
General and Administrative Expenses General and administrative expenses were approximately $2.7 million for the 3 months ended June 30, 2025, compared to $2.9 million for the 3 months ended June 30, 2024, representing a decrease of $0.2 million or 8.1%. This was primarily due to savings resulting from the elimination of an employee position and lower spend on consulting and travel and entertainment expenses.
Net Loss Net losses were $4.7 million for the 3 months ended June 30, 2025, compared to $5 million for the 3 months ended June 30, 2024. This reflects progress in R&D and business activities while maintaining prudent capital management and expense minimization.
Cash, Cash Equivalents, and Marketable Securities As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of approximately $22 million. The company believes available funds will support current operations into the fourth quarter of 2026.
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Operating Highlights
Certepetide: Lisata's proprietary cyclic internalizing RGD peptide product candidate, designed to enhance the effectiveness of anticancer drugs by targeting and penetrating solid tumors. It also modifies the tumor microenvironment to increase susceptibility to immunotherapy and inhibit metastasis.
Strategic Collaborations: Lisata formed a research agreement with Catalent to explore certepetide's use in their antibody drug conjugate platform and a strategic alliance with GATC Health to leverage AI for new drug development candidates.
Financial Performance: Revenue for Q2 2025 was $70,000, primarily from a license fee with Catalent. Operating expenses decreased by 10.6% year-over-year to $4.9 million. Cash reserves stand at $22 million, expected to support operations into Q4 2026.
Clinical Trials: Multiple ongoing trials for certepetide, including ASCEND, BOLSTER, CENDIFOX, and others, with promising preliminary results in pancreatic cancer and other solid tumors. Key milestones and data readouts are anticipated in late 2025 and early 2026.
Intellectual Property: A new composition of matter patent for certepetide was issued, extending protection until March 2040, covering its chemical structure, manufacturing methods, and applications for treating solid tumors.
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Risk or Challenges
Technical difficulties during the call: The CEO mentioned that technical difficulties prevented some speakers from joining the call, which could indicate potential challenges in communication and coordination within the company.
Revenue generation: The company reported only $70,000 in revenue for Q2 2025, which is a very low figure and highlights the company's reliance on external funding and partnerships for financial sustainability.
Operating expenses: Operating expenses were $4.9 million for Q2 2025, with a net loss of $4.7 million, indicating ongoing financial strain and the need for effective cost management.
Funding and cash reserves: The company has $22 million in cash and marketable securities, which is expected to support operations only until Q4 2026, raising concerns about long-term financial sustainability.
Regulatory challenges: The ASCEND trial's original design was not aligned with commercial objectives, requiring amendments to meet regulatory standards, which could delay progress and increase costs.
Dependence on external collaborations: The company relies heavily on partnerships, such as with Catalent and GATC Health, for research and development, which could pose risks if these collaborations face challenges or fail to deliver results.
Pipeline risks: The company’s pipeline is heavily focused on certepetide, and delays or failures in its clinical trials could significantly impact the company’s strategic objectives.
Investigator-initiated trials: Several clinical studies are investigator-initiated, limiting the company’s control over timelines and outcomes, which could lead to delays or unexpected results.
Capital acquisition for Phase III trials: The initiation of a global Phase III trial for metastatic pancreatic cancer is contingent on securing additional capital, posing a risk to the advancement of this critical program.
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Guidance & Outlook
Data-Rich Period: Lisata anticipates a data-rich period over the next 12 months with several key milestones on the horizon.
ASCEND Trial: Final data and key findings from both cohorts of the ASCEND trial are anticipated later this year. The trial evaluates certepetide in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma. Preparations for a Phase III trial are underway, pending capital acquisition.
BOLSTER Trial: Top-line data readout for the first-line cholangiocarcinoma arm is accelerated to the fourth quarter of 2025. Enrollment in the second-line arm has been capped to allow quicker data analysis.
CENDIFOX Trial: Awaiting data from this investigator-initiated study evaluating certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon, and appendiceal cancers.
Qilu Pharmaceutical Collaboration: Qilu Pharmaceutical has completed enrollment in a study of certepetide for metastatic pancreatic cancer. Data are expected in the next 12 to 18 months, with a Phase III study planned thereafter. Lisata will receive a $10 million milestone payment upon the first patient dosing in the Phase III study.
iLSTA Trial: Final data and key findings are anticipated in the first quarter of 2026. The trial evaluates certepetide in combination with immunotherapy and chemotherapy for locally advanced non-resectable pancreatic cancer.
Glioblastoma Multiforme Study: Enrollment is more than 50% complete in a Phase IIa study evaluating certepetide with temozolomide for glioblastoma multiforme. Completion is expected in 2026.
Catalent Collaboration: Preliminary positive data from the collaboration with Catalent on the SMARTag platform could lead to a more extensive license agreement in the future.
GATC Health Collaboration: The partnership aims to analyze certepetide for new indication targets and identify effective combination therapies using AI technology.
Global Phase III Trial: Lisata is planning a global Phase III trial for certepetide in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic cancer, contingent on funding.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide additional insights on the Phase III protocol for the ASCEND trial?
A:The Phase III protocol is expected to be an open-label trial with 650 to 900 patients, depending on the number of dosing arms included. It may include a continuous infusion dosing arm and a 2-dose certepetide dosing arm for comparison. The trial will be powered at 90% with a hazard ratio of 0.75, and the exact design and size will be determined by statistics.
Q:Do you expect spending to remain the same over the next year?
A:Spending will depend on the initiation of the Phase III trial, results of the BOLSTER trial, plans for cholangiocarcinoma indications, and advancement of preclinical products. If no changes are made, a modest decrease in spending is expected as ongoing clinical trials wrap up.
Q:Does the extended cash runway projection include future license revenues or other revenues like tax benefits?
A:The projections only include a small final contribution from the New Jersey sale of NOL program. They do not include capital raises or other infusions, though the company plans to seek funding later this year or early next year for future operations and trials.
Q:What changed with the recent 653 patent compared to previous patents?
A:The 653 patent covers the composition of matter of certepetide, which is a fundamental and difficult-to-work-around patent. This extends the patent life into the 2040s, securing the intellectual property portfolio.
Q:Can you compare the regulatory resistance of the FDA versus China?
A:The comparison is difficult as the company is not a Chinese entity and does not have the same relationships with Chinese regulatory authorities. The FDA has been clear in its guidance for cancer product development, and the company continues to work with them to expedite progress.
Q:Review of Unclear Management Responses
A:Management avoided directly comparing the regulatory resistance of the FDA versus China, citing the company's lack of status as a Chinese entity and the political nature of Chinese regulatory processes.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Congress
FDA
GATC Health
III study
IIa placebo
LLC Research
Phase III
Phase IIa
Phase Ib
Research Division
States certepetide
agreement Catalent
antibody drug
cancer enrollment
certepetide combination
certepetide group
certepetide placebo
development certepetide
dose regimen
drug conjugate
drug development
end
finding
front
mail
month decrease
patent
patient IV
payload
position
property
rate
research license
signal
study certepetide
treatment effect
LSTA Transcript
Lisata Therapeutics, Inc. (LSTA) Q3 2025 Earnings Call Transcript
Unknown11-6
The earnings call summary presents a mixed outlook. The financial performance shows a decrease in expenses and net losses, which is positive. However, the Q&A reveals uncertainties, particularly regarding the timing of trial data and funding for the ASCEND Phase III trial. The market has not reacted positively to clinical data, and management's responses were sometimes vague. The strategic plan highlights promising collaborations and trials, but the lack of immediate catalysts and macroeconomic challenges temper the sentiment. Overall, the sentiment is neutral, reflecting a balance of positive financial health and uncertainties in execution.
Lisata Therapeutics, Inc. (LSTA) Q2 2025 Earnings Call Transcript
Unknown8-8
The earnings call reflects a mixed sentiment. While there are positive developments like reduced losses and strategic collaborations, significant risks remain. The company's reliance on Certepetide and the need for capital for Phase III trials are concerning. The Q&A section did not alleviate these concerns, particularly with management's unclear responses on regulatory challenges. The decrease in expenses and positive cash position are offset by the limited revenue and pipeline risks. Without clear positive catalysts or guidance, the stock is likely to remain stable, resulting in a neutral sentiment.
Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q1 2025 Earnings Call Transcript
Unknown5-9
The earnings call presents a mixed picture: positive aspects include a strong cash position, reduced expenses, and expected milestone payments. However, challenges such as market headwinds, regulatory issues, trial delays, and lack of shareholder return plans offset these positives. The Q&A reveals uncertainties in trial timelines and partnerships, contributing to a cautious outlook. Given these factors, the stock price reaction is likely to remain neutral over the next two weeks, with no significant catalysts to drive a strong movement either way.
Lisata Therapeutics, Inc. (LSTA) Q1 2025 Earnings Conference Call Transcript
Unknown5-8
The earnings call highlights strategic collaborations, reduced operating expenses, and a solid cash position, which are positive. However, the absence of a shareholder return plan, regulatory challenges, and limited control over trial timelines introduce uncertainties. The Q&A session reveals concerns about enrollment impacts and vague management responses, further tempering optimism. Given these mixed signals and the lack of a market cap, the stock is likely to experience minimal movement, leading to a neutral prediction.
LSTA Slides
LSTA Report
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