Lisata Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
- Cohort A of ASCEND trial showed positive survival trends with 4 complete responses in certepetide-treated group vs. none in placebo
- Operating expenses decreased by 11.4% to $5.8 million in Q1 2025
- Net losses reduced to $4.7 million from $5.4 million year-over-year
- Cash runway extended into Q3 2026 with no debt
- Potential $10 million milestone payment from Qilu Pharmaceutical upon Phase 3 progression in China
- FORTIFIDE study remains on hold while investigating alternatives
- GBM study enrollment completion delayed to 2026
- Stopped enrollment in second-line CCA cohort at approximately 20 patients to optimize capital allocation
Insights
Lisata advances certepetide across multiple cancer trials with promising early signals in pancreatic cancer while extending operational runway through strategic program management.
Lisata's Q1 update showcases measured progress across their certepetide development program despite challenging market conditions for small-cap biotechs. The four complete responses observed in Cohort A of the ASCEND trial represents a particularly notable signal given the historically poor response rates in metastatic pancreatic cancer. Complete responses in this indication are exceedingly rare with standard chemotherapy regimens alone.
The company's peptide technology platform presents a differentiated approach by targeting the tumor microenvironment through the C-end rule transport mechanism. Rather than directly killing cancer cells, certepetide aims to enhance delivery of co-administered anti-cancer agents while simultaneously modifying the immunosuppressive tumor microenvironment. This dual mechanism differentiates it from traditional cytotoxic approaches.
Their clinical development strategy demonstrates thoughtful program prioritization. By accelerating the first-line cholangiocarcinoma cohort and capping enrollment in the second-line cohort at 20 patients, management is making pragmatic decisions to generate meaningful data without overextending resources. Similarly, pausing the FORTIFIDE study while exploring more efficient alternatives indicates disciplined capital deployment.
The multiple regulatory designations secured (Fast Track, Orphan Drug for multiple indications, and Rare Pediatric Disease) provide potential development advantages and suggest the compound addresses significant unmet needs. The upcoming data readouts from ASCEND Cohort B, BOLSTER, and CENDIFOX will be critical inflection points that should provide greater clarity on certepetide's clinical profile across different tumor types and treatment combinations.
The diversification strategy through partnerships and collaborations with entities like Catalent (evaluating combination with their ADC platform), ValoTx (oncolytic virus combinations), and the University of Cincinnati (investigating non-oncology applications in endometriosis) represents a capital-efficient approach to expand certepetide's potential application scope while preserving internal resources.
Lisata demonstrates improved capital efficiency with 11.4% reduction in operating expenses while extending cash runway into Q3 2026, providing operational flexibility.
Lisata's first quarter results reflect disciplined financial management with operating expenses decreasing 11.4% year-over-year to
The
The absence of debt strengthens Lisata's financial flexibility, providing cleaner options for potential future partnerships or capital raises. The company's strategic management of trial expenses - such as capping the second-line cholangiocarcinoma cohort and pausing the FORTIFIDE trial while exploring alternatives - demonstrates pragmatic resource allocation focused on generating the most valuable data per dollar spent.
The partnership with Qilu Pharmaceutical for Greater China rights creates potential for non-dilutive funding, with an anticipated
While the net loss of
Encouraging results of Cohort A data from the ASCEND trial presented at ASCO-GI 2025;
Cohort B results from the ASCEND trial accepted for an oral presentation at ESMO-GI 2025
Cash runway extending into the third quarter of 2026 with no debt
Conference call scheduled for today at 4:30 p.m. Eastern Time
BASKING RIDGE, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provided a business update and reported financial results for the three months ended March 31, 2025.
“Lisata maintains momentum into 2025 despite a challenging market for small cap healthcare companies as we continue to make notable progress in both our clinical development portfolio and partnering initiatives,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “Overall, our focus remains on evaluating certepetide in multiple clinical and preclinical studies across a variety of solid tumors and non-cancer indications. In January, positive results stemming from both Cohort A of the ASCEND trial as well as the iLSTA trial were presented at ASCO-GI and we maintain our forecast of a data-rich period for the remainder of 2025 and into 2026. Heading the list of anticipated results are those from Cohort B of the ASCEND trial as well as results from Catalent’s preclinical evaluation combining certepetide with their SMARTag® antibody-drug conjugate (ADC) platform.”
Dr. Mazzo added, “Based on concentrated efforts to manage our finances prudently, we now project having operational cash into the third quarter of 2026 as we finalize next steps in certepetide development, based on upcoming conversations with various regulatory agencies including the FDA, TGA and EMA.”
Development Portfolio Highlights
Certepetide as a treatment for solid tumors in combination with other anti-cancer agents
Certepetide (formerly LSTA1) is a proprietary, internalizing RGD, or iRGD, (arginylglycylaspartic acid) cyclic peptide designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment (TME), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced efficacy of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics in solid tumor models. In addition, to date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care (SoC) chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing or planned preclinical and clinical studies being conducted globally across several solid tumor types in combination with a variety of anti-cancer regimens, including:
- ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial is being conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, is expected in the coming months with a final analysis of both cohorts available thereafter. Preliminary results from Cohort B data have been accepted for presentation at the ESMO Gastrointestinal Cancers Congress being held July 2-5, 2025.
- BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort was added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort and recently decided to stop enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.
- CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. CENDIFOX data are expected in the coming months; however, given that this is an investigator-initiated study, the exact timing is not in Lisata’s control. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.
- Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in the near future. Progression of Qilu’s certepetide development program into Phase 3 in China will trigger a
$10 million milestone payment due to Lisata under the terms of the license agreement with Qilu. - iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. An interim analysis of the iLSTA trial, presented at the 2025 ASCO GI Symposium, showed preliminary results from the first 17 of the 30 targeted patients, corroborating preclinical data that certepetide enhances the effectiveness of immunotherapy treatment. With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025.
- A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is now expected in 2026.
- FORTIFIDE: A proposed Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study in the U.S. evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with SoC in subjects with first-line mPDAC. As part of this study, Lisata has engaged Haystack Oncology to use its MRD™ technology to measure circulating tumor DNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. Initiation of the study remains on hold as the Company is investigating a potentially faster and more cost-effective alternative to achieve the study’s objective, which may become the preferred strategy.
Preclinically, Lisata has entered into multiple research collaborations, including a sponsored research agreement with the University of Cincinnati to assess certepetide in combination with bevacizumab (a VEGF inhibitor) in a preclinical murine model for the treatment of endometriosis. Lisata is also partnering with Valo Therapeutics (ValoTx) to investigate the benefits of combining certepetide with ValoTx's platform technology, PeptiCRAd, an oncolytic virus, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.
Additionally, Lisata recently entered into a research license with Catalent, Inc. (“Catalent”), to evaluate the efficacy of certepetide in a preclinical setting with Catalent’s SMARTag® ADC dual payload technology platform for the treatment of various difficult-to-treat diseases. Lisata also entered into an exclusive license and collaboration agreement with Kuva Labs, Inc. (“Kuva”), in which Lisata granted Kuva an exclusive license to explore the synergistic potential of certepetide as a targeting and delivery agent for Kuva’s NanoMark™ imaging technology in solid tumors.
First Quarter 2025 Financial Highlights
For the three months ended March 31, 2025, operating expenses totaled
Research and development expenses were approximately
General and administrative expenses were approximately
Overall, net losses were
Balance Sheet Highlights
As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities of approximately
Conference Call Information
Lisata will hold a live conference call today, May 8, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.
Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the third quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.
Forward-Looking Statements
This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential of the collaboration with Catalent to develop treatment options; the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com
| Lisata Therapeutics, Inc. | ||||||||
| Selected Financial Data | ||||||||
| (in thousands, except per share data) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| (in thousands, except per share data) | (unaudited) | (unaudited) | ||||||
| Statement of Operations Data: | ||||||||
| Research and development | $ | 2,602 | $ | 3,241 | ||||
| General and administrative | 3,245 | 3,360 | ||||||
| Total operating expenses | 5,847 | 6,601 | ||||||
| Operating loss | (5,847 | ) | (6,601 | ) | ||||
| Investment income, net | 266 | 589 | ||||||
| Other expense, net | (105 | ) | (187 | ) | ||||
| Net loss before benefit from income taxes and noncontrolling interests | (5,686 | ) | (6,199 | ) | ||||
| Benefit from income taxes | (962 | ) | (798 | ) | ||||
| Net loss | (4,724 | ) | (5,401 | ) | ||||
| Less - net income (loss) attributable to noncontrolling interests | - | - | ||||||
| Net loss attributable to Lisata Therapeutics, Inc. common stockholders | $ | (4,724 | ) | $ | (5,401 | ) | ||
| Basic and diluted loss per share attributable to Lisata Therapeutics, Inc. common stockholders | $ | (0.55 | ) | $ | (0.65 | ) | ||
| Weighted average common shares outstanding | 8,602 | 8,294 | ||||||
| March 31, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| Balance Sheet Data: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 25,833 | $ | 31,245 | ||||
| Total assets | 28,981 | 35,002 | ||||||
| Total liabilities | 3,879 | 5,685 | ||||||
| Total equity | 25,102 | 29,317 | ||||||
This press release was published by a CLEAR® Verified individual.
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