Gemcitabine Hydrochloride

BRACELET-1 results in HR+/HER2- metastatic breast cancer surpass expectations, providing meaningful data for a registration-enabling study Data from GOBLET in pancreatic and anal carcinoma support continued development of pelareorep in these indications, with combination studies ongoing Cash position of $15.9 million provides runway through critical milestones into third quarter 2025 Management hosting conference call and webcast this morning at 8:30 a.m. ET SAN DIEGO and CALGARY, AB, March 7, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today reported on highlights and financial results for Q4 and year-end 2024. With its lead candidate, pelareorep, demonstrating strong efficacy signals in breast, pancreatic, and anal cancer, the company is strategically advancing toward registrational studies that could redefine treatment landscapes in multiple high-need indications. All dollar amounts are expressed in Canadian currency unless otherwise noted. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics. Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission. When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients and generate value for our shareholders." Fourth Quarter and Subsequent Highlights GOBLET gastrointestinal cancer data continue to demonstrate pelareorep's potential across multiple indications. Oncolytics presented two posters at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco in January (link to the PR). Promising Data in Anal Cancer with 33% Response Rate, Including a Durable 15+ Month Complete Response: In the ongoing GOBLET study, Oncolytics' pelareorep combination therapy achieved a 33% objective response rate (ORR), including a complete response lasting over 15 months, in twelve evaluable patients with second-line or later unresectable squamous cell carcinoma of the anal canal treated with pelareorep and atezolizumab (link to the poster). This encouraging signal in a very tough-to-treat disease further supports pelareorep's potential in solid tumors. The success criteria in Stage 1 of this Simon two-stage design were previously met; enrollment into Stage 2 of this cohort has begun and will add 18 additional evaluable patients. Data from Stage 2 is expected to determine if there is an efficacy signal sufficient to proceed to a registration-enabling study. Encouraging Progress in Pancreatic Cancer Cohort with Safety Milestone Cleared: GOBLET Cohort 5, with funding from the Pancreatic Cancer Action Network (PanCAN), is treating newly diagnosed metastatic pancreatic ductal adenocarcinoma patients with pelareorep + modified FOLFIRINOX with and without atezolizumab. The protocol-specified safety run-in phase has been completed, and the results were presented at the ASCO GI meeting in January of this year (link to the poster). Following a review of the safety run-in data, an independent Data Safety Monitoring Board recommended that the study continue, and the Paul Ehrlich Institute (PEI), Germany's medical regulatory body, approved this recommendation. Accordingly, enrollment into Stage 1 of this Simon two-stage study, consisting of 30 evaluable patients, has resumed and is ongoing. Ongoing plans to initiate a registration-enabling study in HR+/HER2- metastatic breast cancer. Oncolytics continues to engage with regulators, key opinion leaders, and other relevant stakeholders to finalize the clinical plan for and initiate a large phase 2 study that has the potential to be registration-enabling. We expect a progression-free survival (PFS) readout approximately two years after enrollment begins. The final BRACELET-1 data showed robust improvements for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy in terms of PFS, overall survival (OS), 24-month OS rate, and confirmed objective response rate (link to the PR). These data substantiate the results from IND-213, in which median overall survival was nearly doubled in HR+/HER2- metastatic breast cancer patients who received pelareorep combined with paclitaxel compared to paclitaxel alone. If a PFS benefit comparable to the results seen in BRACELET-1 is observed in the registration-enabling study, the company expects to file for accelerated approval with the FDA. Financial Highlights As of December 31, 2024, the Company reported $15.9 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into the third quarter of 2025. The net loss for the fourth quarter of 2024 was $8.0 million, compared to a net loss of $3.9 million for the fourth quarter of 2023. The basic and diluted loss per share was $0.10 in the fourth quarter of 2024, compared to a basic and diluted loss per share of $0.05 in the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 were $4.6 million, compared to $4.7 million for the fourth quarter of 2023. The decrease was primarily attributable to lower personnel-related expenses related to lower cash annual short-term incentive awards. This decrease was partially offset by increased expenditures related to our clinical trials and share-based compensation expense. General and administrative expenses for the fourth quarter of 2024 were $3.9 million, compared with $4.2 million for the fourth quarter of 2023. The decrease was primarily due to lower personnel-related expenses and lower cash annual short-term incentive awards. The decrease was partly offset by higher share-based compensation expense. Net cash used in operating activities for the twelve months ended December 31, 2024, was $27.0 million, compared to $28.4 million for the twelve months ended December 31, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024. Anticipated Milestones H1 2025: Finalize protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer H2 2025: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer Webcast and Conference Call Management will host a conference call for analysts and investors at 8:30 a.m. ET today, March 7, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 48422. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 48422#. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; the continued development of pelareorep, including through ongoing combination studies; our plans to advance pelareorep to registration-enabling studies for the treatment of breast, pancreatic, and anal cancers, and Oncolytics' expectations regarding the results thereof; our top priority for 2025 being HR+/HER2- metastatic breast cancer; our belief that if we can approximate the benefit seen in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission; the ability of pelareorep to have a meaningful impact for a multitude of patients and generate value for our shareholders; the progression and results of the ongoing GOBLET study, including the enrollment of additional evaluable patients therein and our expectation that data from Stage 2 will determine if there is an efficacy signal sufficient to proceed with a registration-enabling study; enrollment into Stage one of GOBLET Cohort 5; our expectation for a PFS readout approximately two years after enrollment in a registration-enabling study in HR+/HER2- metastatic breast cancer begins; our expectation that Oncolytics will file for accelerated approval with the FDA if a PFS benefit comparable to the results seen in BRACELET-1 is observed in the planned registration-enabling study; our belief that Oncolytics has a projected cash runway through key milestones and into the third quarter of 2025; our anticipated milestones for 2025, including the finalization of protocol for an adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma, enrolling the first patient in a registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer, and receiving initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo: SOURCE Oncolytics Biotech® Inc. 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Promising preliminary Phase 2b (ASCEND) pancreatic cancer data (Cohort A) reported with Cohort B data anticipated in the coming months Enrollment completed in Qilu’s Phase 2 trial evaluating certepetide for the treatment of first-line mPDAC Advancing development portfolio with multiple milestones projected over the next 12+ months Cash runway extending into the second quarter of 2026 with no debt Conference call scheduled for today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., Feb. 27, 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, provides a business update and reports financial results for the twelve months ended December 31, 2024. “Throughout 2024 and now into early 2025, we continue to advance our development portfolio centered around our novel product candidate, certepetide,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “Following the encouraging preliminary results from the ASCEND and iLSTA trials reported at this year’s ASCO-GI Symposium, we remain committed to exploring the broad application of certepetide’s unique mechanism of action. Our development portfolio encompasses multiple clinical and preclinical trials evaluating certepetide for the treatment of various solid tumors, including pancreatic cancer, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer, and melanoma. In addition, we are exploring certepetide’s versatility in non-cancerous settings such as endometriosis. For Lisata, we expect 2025 to be a data-rich year and we look forward to sharing key developments as they become available.” Development Portfolio Highlights Certepetide as a treatment for solid tumors in combination with other anti-cancer agents Certepetide (formerly LSTA1) is an internalizing RGD, or iRGD, (arginylglycylaspartic acid) cyclic peptide designed to selectively 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, diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics. 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 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. The exact timing is dependent on accumulating the requisite number of endpoint events in Cohort B and is not something that can be accurately predicted. 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 has been 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, with enrollment completion targeted for later this year. 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 will 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 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 coming months. iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., is 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. 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 targeted for the second half of 2025. FORTIFIDE: 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. The Company expects to enroll the first patient in the study in the first half of 2025. However, in parallel, management is investigating a potentially faster and more cost-effective approach to achieving the study objective, which may become the preferred strategy. 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. In November 2024, Lisata 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. Under the agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while Lisata will be responsible for supplying certepetide pursuant to a Clinical Supply Agreement. As consideration for the license, the Company is to receive a $1.0 million upfront license fee and is eligible for certain development and commercial milestone payments of up to $19.0 million, as well as a single-digit percentage royalty on net sales. Full Year 2024 Financial Highlights For the year ended December 31, 2024, revenue totaled $1.0 million in connection with an upfront license fee related to the Exclusive License and Collaboration Agreement with Kuva Labs, Inc. The Company did not have any revenue for the year ended December 31, 2023. For the year ended December 31, 2024, operating expenses totaled $23.4 million compared to $25.7 million for the year ended December 31, 2023, representing a decrease of $2.3 million or 8.9%. Research and development expenses were approximately $11.3 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023, representing a decrease of approximately $1.4 million, or 11.0%. This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year, lower spend on chemistry, manufacturing and controls, and lower equity expense. General and administrative expenses were approximately $12.1 million for the year ended December 31, 2024, compared to $13.0 for the year ended December 31, 2023, representing a decrease of approximately $0.9 million or 6.9%. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in equity expenses, a decrease in directors’ and officers’ insurance premiums, and a reduction in spend on legal fees partially offset by one-off settlement related costs and an increase in consulting expenses. Overall, net losses were $20.0 million and $20.8 million for the years ended December 31, 2024 and 2023, respectively. Balance Sheet Highlights As of December 31, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $31.2 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the second quarter of 2026. Net Operating Loss Sale Earlier this year Lisata received $0.9 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by the New Jersey Economic Development Authority (NJEDA). The Program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations with a lifetime cap on the tax benefit sales of $20.0 million. To date, under the Program, the Company has sold $19.6 million in tax benefits for net proceeds of $18.4 million. Conference Call Information Lisata will hold a live conference call today, February 27, 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, the Company encourages 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 second 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 efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other 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. Lisata Therapeutics 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 – Tables to follow – This press release was published by a CLEAR® Verified individual.