Lisata Therapeutics, Inc. (LSTA) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Operating Expenses $4.4 million for Q3 2025, a decrease of $0.9 million or 17.3% year-over-year. This was due to lower research and development expenses and general and administrative expenses.
Research and Development Expenses $2 million for Q3 2025, a decrease of $0.6 million or 22.9% year-over-year. 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 BOLSTER trial costs due to a CRO refund in the prior year.
General and Administrative Expenses $2.5 million for Q3 2025, a decrease of $0.3 million or 12.1% year-over-year. This was primarily due to lower spend on consulting and savings from the elimination of an employee position.
Net Losses $4.2 million for Q3 2025, a decrease from $4.9 million in Q3 2024. This reflects progress in R&D and business activities while maintaining prudent capital management.
Cash and Cash Equivalents $19 million as of September 30, 2025. The company projects that available funds will support current operations into Q1 2027.
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Operating Highlights
Certepetide: Achieved several development milestones, including encouraging preliminary results from multiple studies (ASCEND, iLSTA, CENDIFOX). Demonstrated potential in enhancing anticancer treatment regimens and modifying tumor microenvironments to improve immunotherapy effectiveness.
Strategic Alliance with GATC Health: Formed a partnership to use AI-powered drug discovery for identifying new product candidates, including non-oncology applications.
License Agreement with Catalent: Granted Catalent global rights to evaluate certepetide for use in ADCs, showing improved tumor targeting and efficacy in preclinical studies.
Financial Management: Operating expenses decreased by 17.3% year-over-year for Q3 2025. Cash reserves of $19 million projected to support operations into Q1 2027.
Clinical Trial Progress: Accelerated timelines for BOLSTER trial and other studies, with several data readouts expected in late 2025 and early 2026.
Pipeline Expansion: Exploring new indications for certepetide, including non-oncology applications, and identifying new chemical entities for development.
Intellectual Property: Secured a new composition of matter patent for certepetide, extending protection until March 2040.
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Risk or Challenges
Regulatory Challenges: The ASCEND trial was initially designed with an academic focus rather than commercial and regulatory objectives, requiring amendments to align with regulatory standards. This could delay regulatory approval and commercialization.
Financial Sustainability: The company has cash reserves projected to support operations only until the first quarter of 2027, making future operations contingent on securing additional capital.
Clinical Trial Risks: Several trials, including ASCEND, BOLSTER, and others, are investigator-initiated, limiting Lisata's control over timelines and outcomes. Additionally, some trials are not statistically powered, which may impact the reliability of results.
Dependence on Partnerships: The company relies on partnerships, such as with Catalent and GATC Health, for advancing its pipeline. Any disruptions or failures in these partnerships could adversely affect development progress.
Market and Competitive Risks: Certepetide faces competition in the oncology space, and its success depends on demonstrating clear advantages over existing treatments. Failure to do so could limit market adoption.
Pipeline Diversification Challenges: While the company is exploring non-oncology applications and new indications for certepetide, these efforts are still in early stages and carry inherent risks of failure.
Supply Chain and Manufacturing Risks: The company’s reliance on external entities for manufacturing and supply chain management introduces risks of delays or disruptions, which could impact clinical trial timelines and product availability.
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Guidance & Outlook
Certepetide Development: Final data and conclusions from the ASCEND trial's Cohorts A and B are anticipated in Q1 2026. Phase III trial preparation for certepetide is underway, contingent on capital acquisition. The BOLSTER trial's top-line data readout is accelerated to Q4 2025. Additional data from the CENDIFOX trial are expected in the coming months. The iLSTA trial's final data and key findings are anticipated in Q1 2026. Enrollment for the glioblastoma multiforme study is progressing as planned, with completion expected in 2026.
Strategic Alliances and Licensing: Lisata entered a nonexclusive license agreement with Catalent for the use of certepetide in ADCs, with preclinical data showing enhanced efficacy. A strategic alliance with GATC Health aims to identify new development candidates, with several expected to enter clinical development in 2026.
Financial Outlook: The company projects that available funds will support operations into Q1 2027.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:When should we expect the next Phase IIb data cut for CENDIFOX?
A:The timing of the next Phase IIb data cut for CENDIFOX is uncertain as it is under the control of the investigator at the University of Kansas Cancer Center.
Q:What is the enrollment status for the GBM trial?
A:The GBM trial is on track with a target of enrolling 30 patients, and approximately two-thirds of the target has been achieved.
Q:What does the cash flow runway to the first quarter of 2027 include in terms of expenditures?
A:The cash flow runway includes all operating expenses for the company and expenses to support and complete ongoing clinical trials.
Q:Does the cash flow runway include assumptions for a Phase III trial for ASCEND?
A:No, the cash flow runway does not include assumptions for a Phase III trial for ASCEND.
Q:Why has the share price not reacted positively to robust clinical data?
A:The share price has not reacted positively due to a confluence of negative forces, including a macro environment unfavorable to small-cap biotech, limited trading activity by long-term shareholders, and a volatile stock market. Management believes the market is undervaluing the broad applicability of their product.
Q:Is the biotech achievement award the only award of its type given at this time?
A:Yes, it is the only award with that specific title or name given at this time.
Q:Would it make sense to take a broad-brush approach to potential licensees and use independent consultants on a contingency fee basis?
A:Management is already pursuing a broad-brush approach to potential licensees using internal staff who are well-versed in the product. They do not see the need to use external consultants for this purpose.
Q:What is the expected burn rate for the next five quarters?
A:The burn rate is expected to be roughly $3 million per quarter, but management hopes it will increase to support more studies and generate more data, potentially requiring additional capital.
Q:What are the next steps for the ASCEND Phase III trial given the need for substantial funding?
A:The company plans to find licensees and partners to fund the Phase III trial, as raising the required amount unilaterally would be overly dilutive. Preparations include completing CMC activities, holding regulatory discussions, and engaging with CROs.
Q:Would a pharma partner likely take an indication to move the company forward?
A:Yes, a big pharma partner would likely take an indication, and possibly others, to move the company forward.
Q:Review of Unclear Management Responses
A:Management avoided giving a precise timeline for the next Phase IIb data cut for CENDIFOX, citing the academic investigator's control over the process. Additionally, while discussing the burn rate, management provided a vague response, expressing hope for an increase without specifying concrete plans or figures.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ADC
ADCs
BOLSTER trial
CENDIFOX trial
Catalent
Clinical Trials
Cohort
Cohorts
Congress
Dr Buck
GATC Health
IIa placebo
Phase III
Phase IIa
Phase Ib
achievement
alliance GATC
analog use
application
candidate development
care chemotherapy
care group
certepetide analog
certepetide combination
certepetide standard
chemical
decrease spend
drug discovery
group response
group standard
month decrease
month trial
none standard
patent
property
rate
use payload
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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