Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q1 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Operating Expenses $5.8 million (decrease of $0.8 million, or 11.4% year-over-year) due to reduced spending in clinical research organization expenses and site expenses.
Research and Development Expenses $2.6 million (decrease of $0.6 million, or 19.7% year-over-year) primarily due to a reduction in clinical research organization expenses and site expenses associated with the Phase 2a Bolster trial.
General and Administrative Expenses $3.2 million (decrease of approximately $0.1 million, or 3.4% year-over-year) primarily due to one-off settlement costs in the prior year, partially offset by increased consulting and severance costs.
Net Losses $4.7 million (decrease of $0.7 million year-over-year from $5.4 million) indicating progress in R&D and business activities while maintaining prudent capital management.
Cash, Cash Equivalents, and Marketable Securities Approximately $25.8 million as of March 31, 2025, which is expected to support operations into the third quarter of 2026.
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Operating Highlights
Certepetide Development: Lisata is advancing its clinical development portfolio for Certepetide, targeting solid tumors and other difficult-to-treat diseases. Preliminary results from the ASCEND trial and iLSTA trial presented at the 2025 ASCO GI Symposium show positive trends in overall survival.
Market Positioning: Lisata continues to maintain strong momentum into 2025 despite market headwinds for small-cap healthcare companies, indicating resilience in its market positioning.
Operating Expenses: Operating expenses decreased to $5.8 million in Q1 2025 from $6.6 million in Q1 2024, reflecting a reduction in R&D and administrative costs.
Cash Position: As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities of approximately $25.8 million, expected to support operations into Q3 2026.
Collaborations: Lisata has established collaborations with Valo Therapeutics, Kuva Labs, and Catalent to explore new strategic development opportunities for Certepetide.
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Risk or Challenges
Market Headwinds: Lisata is facing persistent market headwinds for small-cap healthcare companies, which may impact its operations and growth.
Regulatory Challenges: The ASCEND trial was originally designed with academic rather than commercial objectives, leading to necessary amendments that could delay data availability.
Clinical Trial Delays: Data from Cohort B of the ASCEND trial is delayed compared to Cohort A, which may affect the overall timeline for regulatory submissions.
Funding and Capital Management: Lisata is focused on initiating trials that can be funded through existing capital, indicating potential risks if funding is insufficient for future projects.
Investor Control: Several clinical trials are investigator-initiated, limiting Lisata's control over study timelines and outcomes, which may lead to unexpected delays.
Economic Factors: The company’s financial results indicate a net loss of $4.7 million for Q1 2025, which may raise concerns about financial sustainability amid ongoing expenses.
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Guidance & Outlook
Certepetide Development: Lisata is advancing its clinical development portfolio for Certepetide, targeting solid tumors and other difficult-to-treat diseases, with several key milestones anticipated in the next 12 to 18 months.
ASCEND Trial: The ASCEND trial is evaluating Certepetide in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma, with preliminary positive results presented at the 2025 ASCO GI Symposium.
Bolster Trial: The Bolster trial is a Phase 2a trial for cholangiocarcinoma, with enrollment completed ahead of schedule, and top-line data expected in mid-2025.
Collaborations: Lisata has established collaborations with Valo Therapeutics, Kuva Labs, and Catalent to explore new strategic development opportunities for Certepetide.
Financial Outlook: Lisata has approximately $25.8 million in cash and equivalents, expected to support operations into the third quarter of 2026.
Revenue Expectations: Qilu Pharmaceutical is expected to provide a $10 million milestone payment upon dosing of the first patient in their Phase 3 study of Certepetide.
Data Readouts: Key data readouts from various trials are anticipated throughout 2025, contributing to a data-rich year for Lisata.
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Shareholder Return Plan
Shareholder Return Plan: Lisata Therapeutics has not announced any share buyback program or dividend program during this earnings call.
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Key Q&A
Q:Could you provide some more color on whether the capped enrollment in the Bolster study might impact the regulatory path forward?
A:The Bolster trial is a phase 2a proof-of-concept trial not powered to any specific endpoint. The number of patients enrolled is indicative of trends, and with 20 patients, we can determine therapeutic effects with confidence similar to 40 patients. Curtailing enrollment allows us to get data faster, which is important in the current financial climate.
Q:How deep will you be able to go in the data for the ASCEND presentation?
A:The plan for ASCEND data reporting is to present preliminary data for Cohort A and definitive data for Cohort B at ESMO GI in July. The main results will be interpretable after this presentation.
Q:Can you clarify the timeline for Qilu's phase 2 data?
A:We have no control over Qilu's timeline. They are on an innovation pathway in China, which requires them to be the first to approve the product. They may move quickly based on corroborative results from phase 2.
Q:What about the possibility of having manufacturing for trials done by big pharma manufacturers?
A:Most big pharma have minimal excess capacity and typically don’t function as contract manufacturers unless they have a deal. They wouldn’t manufacture small amounts for clinical supplies unless that was their business.
Q:How are you doing strategically in arranging potential partnerships in the endometriosis field?
A:Discussions are very early, with only preliminary data from a mouse study. Most potential partners are more interested in clinically ready assets.
Q:What kind of level of activity is going on with regard to studies of tethered administration?
A:We have announced a collaboration with Catalent to tether Certepetide to their SMARTag ADC platform.
Q:Review of Unclear Management Responses
A:Management appeared to avoid giving a direct answer regarding the timeline for Qilu's phase 2 data, using vague language about their lack of control over the timeline and the strategic decisions made by Qilu.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ASCEND protocol
Cancer
Catalent
Center
Clinical
GI Symposium
Nisco
Phase placebo
Phase study
RD
States combination
Thursday
acquisition
afternoon pleasure
agreement
call
combination care
consulting
development month
email
finding
glioblastoma multiforme
iLSTA trial
imaging
license
mPDAC
month decrease
objective
opportunity
patient criterion
payload
phase placebo
platform
product candidate
timeline
trial ASCO
trial iLSTA
trial investigator
tumor disease
website presentation
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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