LSTA

Image source: The Motley Fool. Thursday, Nov. 6, 2025 at 4:30 p.m. ET President and Chief Executive Officer — Dr. David J. Mazzo Executive Vice President of Research and Development and Chief Medical Officer — Dr. Kristen K. Buck Senior Vice President of Finance and Treasury and Chief Accounting Officer — James Nisco Need a quote from a Motley Fool analyst? Email [email protected] Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer; and James Nisco, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our third quarter 2025 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received the news release or if you would like to be added to the company's email distribution list, please subscribe to the email alerts on the company website or email me at [email protected] to be added. Sorry. Before we begin, I remind you that comments made by management during this conference call contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata Therapeutics. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, its Forms 10-Q, 8-Ks, and 10-Ks, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, November 6, 2025. Lisata Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, I will now turn the call over to Dr. David Mazzo. Dave? David Mazzo: Thank you, John, and good afternoon, everyone. It's my pleasure to provide the latest update of Lisata Therapeutics' recent business highlights, discuss our third quarter 2025 financial results, and give a report on the progress of our development programs. Building on the momentum from the first half of the year, Lisata Therapeutics achieved several development milestones involving cerdepatide, including the announcement of encouraging preliminary results from multiple studies including the ASCEND trial, the IELISTA trial, and the SENDFOX trial, adding further corroboration to our expectations of the positive impact of cerdepatide as part of various anticancer treatment regimens. On the business development front, we entered into a strategic alliance with GATC Health to use their multinomial Advanced Technology Artificial Intelligence Drug Discovery platform to identify product candidates for development. We also executed a nonexclusive global license agreement with Catalent in which Catalent gains access to cerdepatide and its analogs for use as a payload for their SmartTag ADC technology platform. We continue to anticipate that the next several quarters will be a data and transaction-rich period for Lisata Therapeutics with several key milestones on the horizon. Following the review of our financial results, Dr. Kristen Buck, our Chief Medical Officer and Head of R&D, will provide an update on our ongoing and planned clinical studies, including timelines and key achievements. With that, I will now turn the call over to James Nisco, Senior Vice President of Finance and Treasury and Chief Accounting Officer. James? James Nisco: Thanks, Dave. Good afternoon, I'm pleased to join you today to present a summary of our third quarter 2025 financial results. Next, a review of our operating expenses. For the three months ended September 30, 2025, operating expenses totaled $4.4 million compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $900,000 or 17.3%. Research and development expenses were approximately $2 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $600,000 or 22.9%. 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 the bolster trial costs as a result of a CRO refund in the prior year quarter related to trial protocol modifications. On a year-over-year comparison, for the nine months ended September 30, 2025, bolster trial costs are lower than the prior year. General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $300,000 or 12.1%. This was primarily due to lower spend on consulting and savings from the elimination of an employee position. Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024. It is noteworthy that we continue to make progress according to our plans for our R&D and business activities while continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of September 30, 2025, we had cash and cash equivalents of approximately $19 million. Based on our existing and planned activities, the company projects that available funds will support current operations into 2027. With that, I will now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs. Kristen Buck: Thank you, James, and good afternoon, everyone. It's a pleasure to be here today to present an update on our clinical development portfolio, including near-term catalysts. As mentioned on previous quarterly calls, Lisata Therapeutics is focused on the development of its proprietary cyclic internalizing RGD peptide product candidate, cerdepatide, for the treatment of advanced solid tumors and other difficult-to-treat diseases. Cerdepatide is designed to activate a novel uptake pathway that allows co-administered or tethered anticancer drugs to selectively target and penetrate solid tumors more effectively. In addition, cerdepatide has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore increasing the tumor's susceptibility to immunotherapy and our body's own immune system while also inhibiting the metastatic cascade. If you'd like more information regarding cerdepatide's mechanism of action, we encourage you to visit our website where you'll find an animated video and relevant slides within our corporate presentation. On the regulatory front, cerdepatide has secured multiple special designations from both the U.S. FDA and EMA, all of which are also listed on our website and in the corporate presentation for your easy reference. Now for an update on our individual development programs. The ASCEND trial is a Phase 2b 158 patient, double-blind, randomized, placebo-controlled clinical trial evaluating cerdepatide in combination with standard of care gemcitabine and nab-paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, or M-DAC. Patient recruitment was conducted at 25 sites in Australia and New Zealand and is sponsored by the Australasian Gastrointestinal Clinical Trials Group or AGITG in collaboration with the National Health and Medical Research Council Clinical Trial Center at the University of Sydney. As we mentioned in the past, this investigator-initiated trial was inherited upon our acquisition of Send Therapeutics. The original trial was designed with an academic bench rather than one with commercial and regulatory objectives and was statistically powered based on a six-month progression-free survival primary endpoint. This endpoint is unusual in that it has not been previously used as the basis of approval for an anticancer drug. After the acquisition, we collaborated with the AGITG to modify the trial to ensure it measured clinical endpoints that would best support the next steps in the development of cerdepatide from a regulatory perspective. To that end, the ASCEND protocol was amended to include another cohort of patients, Cohort B, not statistically powered to evaluate an additional cerdepatide dosing regimen. The ASCEND protocol was also amended to capture overall survival outcomes for both cohorts A and B as overall survival is considered by regulatory authorities to be the gold standard endpoint in pancreatic cancer trials. Since the ASCEND protocol was amended following trial initiation, data from Cohort B are being analyzed sequentially following Cohort A data. Cohort A with 95 patients receiving a single intravenous dose of cerdepatide or placebo in combination with standard of care completed enrollment in 2023. As announced in January, preliminary Cohort A data was presented at the 2025 ASCO GI Symposium which showed a positive trend in overall survival in the cerdepatide plus standard of care chemotherapy group, including four complete responses in this group compared to none in the standard of care plus placebo-treated group. Most recently, preliminary data from Cohort B with 63 patients receiving two intravenous doses of cerdepatide 3.2 mg/kg or placebo, administered four hours apart in combination with standard of care chemotherapy were presented at the ESMO Gastrointestinal Cancers Congress on July 2, 2025. These data showed a positive trend in progression-free survival, overall survival, and objective response rate in the cerdepatide plus standard of care treatment group compared to the standard of care plus placebo-treated group. Another complete response was also noted in the cerdepatide plus standard of care treated group while none were observed in the standard of care plus placebo group. Additionally, pooled data from both cohorts A and B which was presented at the ESMO Congress on October 20, 2025, further corroborated previous findings and indicated no increased adverse events in the cerdepatide plus standard of care treated group beyond those experienced in the standard of care plus placebo-treated groups. Final data and conclusions from both cohorts are anticipated for 2026. As we've previously announced, we have completed an end of Phase II meeting with the FDA and in conjunction with other correspondence with the agency, have an agreement on the fundamental aspects of an acceptable global Phase III protocol including dose and dosing regimen, blinding, and primary endpoints. Subsequently, we have begun preparation for Phase III trial initiation as contingent upon available capital and anticipated capital acquisition. The BOLTAR trial is our Phase 2a double-blind placebo-controlled multicenter randomized trial in the United States evaluating cerdepatide in combination with standard of care chemotherapy and immunotherapy in first and second-line cholangiocarcinoma on top of standard of care. Enrollment was completed in the first-line cholangiocarcinoma arm nearly six months ahead of plan, accelerating anticipated top-line data readout to 2025. Based on encouragement from multiple investigators involved in the trial, a second cohort was added evaluating cerdepatide in subjects in second-line cholangiocarcinoma. Although originally planned to recruit 40 patients, enrollment was ultimately capped at approximately 20 patients to allow for quicker data analysis and a more efficient use of our capital. It should be noted that this exploratory trial is not statistically powered. However, the reduced number of patients in the second-line arm should be sufficient to determine if there is a treatment effect. The SENDFOX trial is a Phase IbIIa open-label trial in the States evaluating cerdepatide in combination with neoadjuvant fulphuranox-based therapies in pancreatic, colon, and appendiceal cancers. In December 2024, the company announced enrollment completion in all three cohorts. This single-center study being conducted at the University of Kansas Cancer Center was designed with a three-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 met these criteria and were treated with cerdepatide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancers with peritoneal metastases, and 11 with oligometastatic colon cancer. Preliminary data from the pancreatic cancer cohort presented at the AACR Special Conference in September 2025, showed that the combination of cerdepatide with fulphuranox was safe and feasible. In the ten patients who completed the therapy and underwent surgery, treatment resulted in a 50% R0 resection rate and a 70% pathological partial response alongside promising early survival data, including a 60% two-year overall survival rate. Importantly, the combination therapy appears to transform tumors from immuno-cold to immuno-hot by enhancing immune cell infiltration and increasing markers like PD-1 and PD-L1 which could significantly improve the effect of subsequent immunotherapies. Additional data from the SENDFOX trial are anticipated in the coming months. The trial is funded by the University of Kansas Cancer Center and Lisata Therapeutics is supplying cerdepatide. Chiso Pharmaceutical, the licensee of cerdepatide in the Greater China territory, is running a parallel development program for cerdepatide in combination with gemcitabine and nab-paclitaxel as a treatment for metastatic pancreatic cancer. Chilu previously reported that they completed enrollment in the study of 90 subjects. However, we still await data from the study to be shared. Also, according to guidance last received from Chilu, data are expected in the next twelve to eighteen months and we anticipate ongoing dialogue to continue related to potential next steps in their development plan. The IELISTA trial is a Phase 1b2a randomized placebo-controlled three-arm single-blind single-center trial evaluating the safety, early efficacy, pharmacodynamics of cerdepatide in patients with locally advanced non-resectable pancreatic cancer. The trial is being conducted in Australia in collaboration with AstraZeneca, and the funding sponsor WARP nine, combining cerdepatide with the checkpoint inhibitor durvalumab both standard of care gemcitabine and nab-paclitaxel chemotherapy versus cerdepatide in combination with standard of care chemotherapy without durvalumab versus standard of care alone. As recently announced, enrollment in the IELISTA study is complete. An updated interim analysis presented at ESMO GI Congress on July 3, 2025, revealed compelling positive preliminary data for cerdepatide. These data are consistent with earlier findings from the 2025 ASCO GI meeting further reinforcing cerdepatide's potential to significantly enhance immunotherapy effectiveness by provoking significant RECIST responses improving overall response and disease control rates. Final data and key findings from this study are anticipated in 2026. A study of cerdepatide in combination with temozolomide in patients with glioblastoma multiforme, or GBM, brain cancer has been initiated with many patients already enrolled and treated. The study is designed as a Phase 2a double-blind placebo-controlled randomized proof of concept study evaluating cerdepatide when added to standard of care temozolomide versus temozolomide alone and matching placebo in subjects with newly diagnosed GBM. This actively enrolling study is being conducted across multiple sites in Estonia, Latvia, and Lithuania. The study is targeted to enroll 30 patients with a randomization of two to one plus standard of care versus placebo plus standard of care. Enrollment is progressing according to plan and completion of enrollment is expected in 2026. As a reminder, several of the clinical trials I mentioned are investigator-initiated trials, meaning Lisata Therapeutics has limited control over study timelines and expectations may be subject to change. That said, we are incredibly grateful to the investigators and especially to the patients participating in cerdepatide clinical trials around the world. For more information on each trial, please refer to the appendix section of our corporate presentation on our website. The presentation also includes two slides illustrating the anticipated timelines and execution of key milestones and data readouts. Moving on to exciting business development achievements. As Dave mentioned earlier, Lisata Therapeutics and Catalent entered into a nonexclusive license agreement that grants Catalent global rights to evaluate cerdepatide and its analogs for use as SmartTag payloads across multiple antibody-drug conjugates, or ADCs, designed to address difficult diseases, including advanced solid tumors. As presented at the World ADC Conference earlier this week, compelling positive data from Catalent's preclinical study showed both improved tumor-selective penetration and enhanced efficacy, further highlighting cerdepatide's strong potential to significantly improve the targeting and overall effectiveness of ADCs in advanced solid tumors. Additionally, we've established a strategic alliance with GATC Health. This partnership combines Lisata Therapeutics' drug development expertise with GATC's AI-powered Multiomics advanced technology platform to accelerate and optimize drug discovery. This includes in silico assessment of cerdepatide for new indications, including some outside of oncology, as well as identifying new chemical entities and/or repurposed existing drugs for diseases with high unmet needs, including non-oncology applications with and without cerdepatide. The Alliance has already identified a number of development candidates, several of which are anticipated to translate into clinical development during 2026. Further strengthening our intellectual property portfolio, the United States Patent and Trademark Office issued a new composition of matter patent for cerdepatide in July 2025, extending our protection until March 2040 with the potential for further extensions. The patent's claim covers cerdepatide's chemical structures, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumors. With that, I will now turn the call back to Dave. David Mazzo: Thanks, Kristen. In summary, the past quarter has been active and fruitful as we have both advanced the broad development of cerdepatide while identifying means by which to expand and diversify Lisata Therapeutics' development pipeline. We continue to evaluate opportunities to bring new products to patients across a variety of cancer and non-cancer indications, and I look forward to sharing our progress on future calls. With that overview, operator, we're now ready to take questions. Operator: Thank you. You will then hear an automated message advising that your hand is raised. Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions. Your first question comes from the line of Joe Panccinis with H.C. Wainwright. Your line is open. Lander Egaña-Gorroño: Hello, everyone. This is Lander on for Joe. Thanks for our questions. So for SENDFOX, when approximately should we expect the next phase to be data cut? And for the GBM trial, could you provide some color on the enrollment status for the target sample size? Thank you. David Mazzo: Hi, Lander. Thanks for joining and for asking the questions. On SENDFOX, unfortunately, we really cannot give a very precise estimate of when the next data cut will be made available because it's really under the control of the investigator at the University of Kansas Cancer Center. So we'll stay close to him. We obviously encourage him to keep things moving along. But the academic world moves at a different pace than the commercial development world. And then, as it relates to, what was your second question? Lander Egaña-Gorroño: The GBM trial enrollment status. David Mazzo: As it relates to the GBM trial, as Kristen mentioned, we're completely on track with that. The target is to enroll 30 patients. I would say that we're approximately two-thirds of the way through. So things are moving very well according to plan. Lander Egaña-Gorroño: Perfect. That's very helpful. Thank you so much. David Mazzo: Thank you. Operator: Your next question comes from the line of Robert Sassoon with Water Tower Research. Your line is open. Robert Sassoon: Thank you. Just a couple of questions. Your cash flow runway to 2027, what is that should be can you sort of run through what I think will include in terms of expenditures going into February 2026? David Mazzo: Yes, sure. So thanks for the question. James is on the line if we want to go into more detail. But generally speaking, that covers all of the operating expenses for the company, as well as all the expenses to support the ongoing and complete the ongoing clinical trials. Robert Sassoon: Is there any sort of assumption of a Phase III trial for ASCEND actually incorporated into those assumptions? David Mazzo: There is not. Robert Sassoon: Okay. And one more question for me. I mean, you've come out with some pretty robust clinical data, a series of them, in the past year. And your share price hasn't really reacted to it in the way that one would expect for that type of data. What do you think the investors are missing? David Mazzo: Oh, everything, candidly. I think the problem is a confluence of negative forces that seem to be affecting lots of small-cap companies. But especially frustrating for Lisata Therapeutics where, as you pointed out, we continue to generate positive results across a wide variety of studies, we continue to manage our capital extremely prudently, we continue to make very, I think, astute business deals, and yet the stock doesn't react. I think that's partly because the macro environment is not favoring small-cap biotech these days. There aren't quite a lot of buyers. We're also stuck in a difficult situation because many of our shareholders treat their holdings in Lisata Therapeutics as a venture capitalist might. In other words, they've made their purchases quite a while ago and they're holding for the long run, so they don't trade. And with a limited float like we have on a given day, a very small number of trades could make the market. And that makes our stock somewhat volatile. So I think we are continuing to look for ways to break that paradigm. And our best efforts are to continue to do positive transactions and generate positive data. But in terms of what the market is missing, I think they're missing that there's quite a lot of value in a product that can be used and we've demonstrated now that it can be used very broadly across a number of different types of cancers in a variety of different combinations. Robert Sassoon: Okay, thank you for that answer. That sounds really plausible. I'll just jump back into the queue. David Mazzo: Thank you. Operator: Next question comes from the line of Pete Enderlin with MAZ Partners. Your line is open. Pete Enderlin: Thank you. Hi, everybody. First, you know, this biotech achievement award, breakthrough award that you got, overall is the word used. Does that mean that you're the only one that got that? I mean, there might be other lesser awards, but is that basically the only number one award of that type given in for at this time? David Mazzo: I think we can say that's the only award with that title or name. Yes, Pete. Pete Enderlin: Okay. I mean, it seems sort of trivial, the reason I'm asking that is and Dave, you said before that you know, potential licensees or partners want to see more clinical results. And also, of course, we've seen a lot of positive results recently, but somebody else said the stock hasn't responded. And, you know, given the broad application of cerdepatide and maybe some other aspects too in immunotherapy and chemotherapy. The question that I'm really getting at is wouldn't it make sense to take a broad brush approach to potential licensees and make a push for that now that you're starting to gain some momentum and you know, that you could use the ones that you've gotten Catalent, and the other for kind of referrals, and therefore you know, kind of beat the bushes for some additional licenses given that for example, Catalent is a nonexclusive license. They would all be exclusive because each one would apply to a particular disease and a particular drug. And I know you're probably going to say they cost money, but I have an idea to address that too, which is what about using independent consultants on a contingency fee basis to go out and do that beating the bushes to get licensees I know that's a lot, but I just wanted to throw it all out there. David Mazzo: No. No. And I think you've done actually, in the form of a question, you've actually done a nice job of describing our actual ongoing strategy and execution. That's exactly what we're doing. And we don't need to do that with external consultants. We do that with our internal staff who know the product extremely well. And, you know, so that's exactly what we're doing on a regular basis. And we're building on the momentum of the previous nonexclusive licenses and the interest that was shown in those deals to generate new interest and hopefully build a greater consortium of different licensees. Pete Enderlin: Okay, great. And just following up on a previous question, the I guess the burn rate looks like it'll be roughly $3 million per quarter for the next five quarters. Is it going to be fairly level over that period of time? David Mazzo: Well, let me put it this way. And listen carefully to the way I state this so I'm not misquoting anyone. But I hope not. I actually hope it's going to go up. And I want it to go up because I want us to be doing more studies which will be generating more data, which is how a company like Lisata Therapeutics ultimately generates value for shareholders. Now of course to do that, we'll likely have to raise some capital to supplement our current balance sheet. But that would be the plan. Now there are ways for capital to come in through licensing fees, etcetera, that are non-dilutive and of course we'll give those priority. Pete Enderlin: Right. Okay, great. Thanks very much. Operator: Next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Your line is open. Kemp Dolliver: Great. Thank you. You know, with the final analysis from the ASCEND data coming, you know, relatively soon, could you talk about your thinking for the next steps? Because you know, as everybody on this call knows you need to raise a substantial amount of money to fund the phase three. And you know, there's some orchestration that goes on to get that done. And so I'd like to know your thinking about you know, the steps in the process you'll lay out to do so. David Mazzo: Thanks, Kemp, for the question. And actually the opportunity to be clear on what our plans are. So based upon the data that's been generated from the Phase 2b trial, we've concluded internally that the drug deserves further development and that moving to phase three would be the logical next step. Clearly, in this current financing environment, it's going to be next to impossible to raise the amount of money necessary to unilaterally fund that phase three in a manner that would not be so overly dilutive to current shareholders as to be distasteful. So we are working much to Pete's suggestion, the previous questioner, working to find licensees and partners who will be willing to bear the brunt of that funding or at least contribute in an equal matter to that funding so that we can get that trial done. In the meantime, we've done everything we can and continue to do everything we can internally with existing resources to be prepared to move into Phase III including completing activities on the CMC side that would have us poised for phase three production and NDA validation lot production, having the end of phase 2B meeting with FDA to discuss and agree on a protocol, and preparing similar discussions with other regulatory agencies around the world looking for some consensus on a global protocol. Beginning to have early dialogue with CROs that might be involved in certain areas. And of course, looking for partners and means to fund that trial. Kemp Dolliver: Okay. And to be clear, this would be along the line. Predominantly on the along the lines of what you know, it would be a pharma partner who would take an indication. This indication may be other indications in order to move the company forward. David Mazzo: That's likely the structure of a pharma deal. David Mazzo: Thank you. Thanks, Kemp. This concludes the question and answer session. Operator: I will now turn the call back over to Dr. Mazzo for closing remarks. David Mazzo: Well, again, thank you all for participating in today's call, and we remain grateful for your continued interest and support in Lisata Therapeutics. Stay well and have a good evening. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. 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This article first appeared on GuruFocus. Release Date: November 06, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lisata Therapeutics Inc (NASDAQ:LSTA) achieved several development milestones with their product candidate certepetide, showing positive preliminary results in multiple studies. The company entered into a strategic alliance with GATC Health to leverage AI technology for drug discovery, enhancing their development capabilities. Lisata Therapeutics Inc (NASDAQ:LSTA) executed a non-exclusive global license agreement with Catalan, allowing Catalan to use certepetide in their Smart Tag ADC technology platform. Operating expenses decreased by 17.3% year-over-year, demonstrating effective cost management. The company has cash and cash equivalents of approximately $19 million, projected to support operations into the first quarter of 2027. Despite positive clinical data, Lisata Therapeutics Inc (NASDAQ:LSTA)'s share price has not reacted as expected, possibly due to macroeconomic factors affecting small-cap biotech companies. The company needs to raise substantial funds to support a phase 3 trial, which may be challenging in the current financing environment. Lisata Therapeutics Inc (NASDAQ:LSTA) faces limited control over timelines for investigator-initiated trials, which could affect the pace of development. The company's current cash flow projections do not include funding for a phase 3 trial, indicating a need for additional capital. There is a reliance on partnerships and licensing deals to fund future trials, which may not materialize as planned. Warning! GuruFocus has detected 3 Warning Signs with LSTA. Is LSTA fairly valued? Test your thesis with our free DCF calculator. Q: When should we expect the next phase of data cut for the Sendafox trial, and could you provide an update on the enrollment status for the GBM trial? A: Unfortunately, we can't provide a precise estimate for the next data cut for the Sendafox trial as it's under the control of the investigator at the University of Kansas Cancer Center. Regarding the GBM trial, we are on track with enrollment, having completed approximately two-thirds of the target 30 patients. Dr. David Mazzo, CEO Q: Could you explain what the cash flow runway to the first quarter of 2027 includes in terms of expenditures? A: The cash flow runway covers all operating expenses for the company and expenses to support and complete ongoing clinical trials. There is no assumption of a Phase 3 trial included in these projections. Dr. David Mazzo, CEO Q: Despite robust clinical data, the share price hasn't reacted as expected. What do you think investors are missing? A: The lack of reaction is likely due to a confluence of negative forces affecting small-cap companies, including a macro environment not favoring small-cap biotech. Many shareholders treat their holdings as long-term investments, leading to limited trading and stock volatility. The market may be missing the broad applicability and value of our product across various cancer types. Dr. David Mazzo, CEO Q: With the final analysis of the Ascend data coming soon, what are the next steps, especially regarding funding for Phase 3? A: Based on Phase 2B data, we believe the drug deserves further development into Phase 3. However, raising funds unilaterally for Phase 3 is challenging in the current environment. We are seeking partners to share funding responsibilities. Internally, we are preparing for Phase 3 by completing necessary activities and engaging in early dialogues with CROs and regulatory agencies. Dr. David Mazzo, CEO Q: Would it make sense to pursue a broad approach to licensing, given the momentum and non-exclusive nature of current licenses? A: Yes, we are actively pursuing this strategy internally without external consultants. We are building on the momentum of previous non-exclusive licenses to generate new interest and expand our consortium of licenses. Dr. David Mazzo, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Data rich period continues to support certepetide’s broad applicability and effectiveness Catalent enters into global license agreement for the use of certepetide as part of their SMARTag® Antibody-Drug Conjugate Technology Platform Strategic Alliance formed with GATC Health to exploit their Multiomics Advanced Technology™ artificial intelligence drug discovery platform Cash runway extended into the first quarter of 2027 with no debt Conference call scheduled for today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., Nov. 06, 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 third quarter ended September 30, 2025. “Once again, the recent quarter saw the reporting of positive data from a number of clinical studies involving certepetide, including from the ASCEND, iLSTA, and CENDIFOX trials. Importantly, we also announced a strategic alliance with GATC Health to use their Multiomics Advanced Technology™ artificial intelligence drug discovery platform to identify product candidates for development, as well as a global license agreement in which Catalent gained access to certepetide for use across various Antibody-Drug Conjugates. Overall, it was a productive and positive quarter marked by our continued vigilance in managing expenses. As a result, we now project that our available cash will fund current operations into the first quarter of 2027,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “We anticipate a steady flow of additional data through the remainder of 2025 and into 2026.” Development Portfolio Highlights Certepetide as a treatment for solid tumors in combination with other anti-cancer agents Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug 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 clinical and non-clinical data demonstrating enhanced efficacy and acceptable safety of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, RNA-based therapeutics, and Antibody-Drug Conjugates (“ADCs”) in solid tumor models. 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 and proposed (subject to sufficient funding) global clinical studies 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 standard-of-care (“SoC”) chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The trial was 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. Preliminary 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, was presented at the ESMO Gastrointestinal Cancers (“ESMO-GI”) Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Additionally, pooled data from both Cohorts A and B, which was presented at the ESMO Congress in October 2025, further corroborated previous findings and indicated no increase in adverse events in the certepetide-treated groups beyond those experienced in the SoC alone groups. Final data and key findings from both cohorts of the ASCEND study are anticipated for the first quarter of next year. 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 fourth quarter of 2025. Based on investigator enthusiasm, a second cohort was added, evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced the first patient treated in the second-line CCA cohort and more recently, completed enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation. CENDIFOX: Investigator-initiated 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 ductal adenocarcinoma (“PDAC”), 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. Preliminary data from the PDAC cohort, presented at the AACR Special Conference in September 2025, showed that the combination of certepetide with FOLFIRINOX was safe and feasible. In the 10 patients who completed the therapy and underwent surgery, treatment resulted in a 50% R0 resection rate and a 70% pathologic partial response, alongside promising early survival data, including a 60% two-year overall survival rate. Importantly, the combination therapy appears to transform tumors from "immune-cold" to "immune-hot" by enhancing immune cell infiltration and increasing markers like PD-1 and PD-L1, which could significantly improve the efficacy of subsequent immunotherapies. Additional CENDIFOX data are expected in the coming months under the auspices of the investigator. 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 developing 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 2026. iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., a non-profit foundation, 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. Study enrollment is complete and results from an interim analysis were presented at the ESMO-GI Congress on July 3, 2025, showing compelling new corroborative data for certepetide. Consistent with the earlier findings presented at the 2025 ASCO-GI meeting, the data demonstrate certepetide's potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data from this study are anticipated in the first quarter of 2026. GBM: A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus SOC 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 is progressing according to plan and completion is expected in 2026. Notable business development achievements in the third quarter: Lisata and Catalent entered into a nonexclusive license agreement that grants Catalent global rights to evaluate certepetide and its analogs for use as SMARTag® payloads across multiple ADCs designed to address difficult-to-treat diseases. As presented at the World ADC conference earlier this week, compelling positive data from Catalent’s preclinical study evaluating certepetide and its analogs as non-cytotoxic SMARTag® ADC payloads showed not only improved ADC efficacy but broadened distribution of the cytotoxic payload within the tumor, supporting certepetide’s potential to enhance the targeting, penetration, and effectiveness of ADCs in advanced solid tumors. Lisata entered into a strategic alliance with GATC Health to exploit GATC's AI-powered Multiomics Advanced Technology™ artificial intelligence drug discovery platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies. Third Quarter 2025 Financial Highlights Operating Expenses For the three months ended September 30, 2025, operating expenses totaled $4.4 million, compared to $5.3 million for the three months ended September 30, 2024, representing a decrease of $0.9 million or 17.3%. Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024, representing a decrease of $0.6 million or 22.9%. 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 the BOLSTER trial costs. General and administrative expenses were approximately $2.5 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, representing a decrease of $0.3 million or 12.1%. This was primarily due to lower spend on consulting and the elimination of an employee position. Overall, net losses were $4.2 million for the three months ended September 30, 2025, compared to $4.9 million for the three months ended September 30, 2024. Balance Sheet Highlights As of September 30, 2025, we had cash and cash equivalents of approximately $19.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the first quarter of 2027. Conference Call Information Lisata will hold a live conference call today, November 6, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below: Dial-in information: Participant Toll-Free dial: (800) 715-9871 Participant Toll/Int'l dial: (646) 307-1963 Conference ID: 6375221 To avoid delays, we encourage participants to dial into the conference call 10 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 first quarter of 2027, encompassing anticipated data milestones from its ongoing clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative 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 solid tumors; our beliefs about the potential uses and benefits of certepetide; the potential of the collaboration with Catalent to develop new treatment options; the expected expiration of our patents for certepetide; our ability to obtain patent term extension on our U.S. composition of matter patent; 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 preliminary data 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: Media and Investors: Lisata Therapeutics John Menditto Vice President, Investor Relations and Corporate Communications Phone: 908-842-0084 Email: [email protected] This press release was published by a CLEAR® Verified individual.

Results to be presented at the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research—Emerging Science Driving Transformative Solutions BASKING RIDGE, N.J., Sept. 29, 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, today announced encouraging preliminary data from the pancreatic ductal adenocarcinoma (“PDAC”) cohort of the Phase 1/2a CENDIFOX trial (NCT05121038). The investigator-initiated trial, led by Anup Kasi, M.D., M.P.H., at The University of Kansas (“KU”) Cancer Center, is evaluating Lisata's proprietary investigational iRGD cyclic peptide product candidate, certepetide, in combination with FOLFIRINOX-based therapies for the treatment of pancreatic, colon, and appendiceal cancers. The preliminary data will be presented in poster A070, titled “CENDIFOX: Phase I/II Trial of CEND-1 (LSTA1, certepetide) with Neoadjuvant mFOLFIRINOX in Resectable and Borderline Resectable PDAC,” at the American Association for Cancer Research (“AACR”) Special Conference in Cancer Research: Advances in Pancreatic Cancer Research—Emerging Science Driving Transformative Solutions on September 29, 2025, from 4:30 p.m. - 7:00 p.m. in Boston, Massachusetts. The poster presentation will highlight findings from patients with resectable and borderline resectable PDAC, with the full abstract available on the AACR website. “The preliminary trial data has been very promising, and we’re excited to share these findings with the broader oncology community,” stated Dr. Anup Kasi. “The ability of certepetide to improve drug delivery and influence the tumor microenvironment may offer a potential new and exciting treatment approach for pancreatic cancer. We are optimistic studies like CENDIFOX will pave the way for more effective combination therapies for difficult-to-treat solid tumor cancers.” “The initial results from the CENDIFOX trial are very encouraging, showing that certepetide can enhance the effectiveness of standard-of-care chemotherapy in pancreatic cancer,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “We believe these findings are a significant step forward in a disease with few beneficial treatment options. By improving drug delivery and modulating the tumor microenvironment to re-engage the immune system, we see a path forward for this program and the potential to change the outlook for patients.” The abstract highlights that the combination of certepetide with FOLFIRINOX was safe and feasible in patients with resectable and borderline resectable PDAC, with no serious adverse events attributed to certepetide. Among the 35 patients enrolled in the PDAC cohort, 10 completed the protocol-prescribed pre-surgical courses of therapy and were eligible to undergo pancreatic cancer resection. Based on these 10 patients, the R0 resection rate (no residual cancer at the surgical margins) was 50%, and 70% experienced a pathologic partial response. The results also demonstrated promising early survival data, including a 60% two-year overall survival rate and a 12-month median disease-free survival. Additionally, analysis of tumor tissue demonstrated enhanced immune cell infiltration, along with increased expression of immune markers such as CD68, PD-1, and PD-L1. These findings support the potential of certepetide to transform pancreatic tumors from “immune-cold” to “immune-hot,” which may make them more responsive to immunotherapies. Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. With a five-year survival rate of just 13%, underscoring the aggressive nature of the disease and the limited efficacy of existing treatments. This highlights the need for the significant investment in new approaches, including targeted therapies and treatment options. About Certepetide Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including 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 test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. 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 (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). 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 fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative short film. For more information on the Company, please visit www.lisata.com. About The University of Kansas Cancer Center The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Masonic Cancer Alliance. 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 solid tumors; our beliefs about the potential uses and benefits of certepetide; the potential of the collaboration with Catalent to develop new treatment options; the expected expiration of our patents for certepetide; our ability to obtain patent term extension on our U.S. composition of matter patent; 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 preliminary data 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: [email protected] Media: ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: [email protected] University of Kansas Cancer Center Contact: Media: Kay Hawes Associate Director of News and Media Relations [email protected] _______________ 1 Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63. This press release was published by a CLEAR® Verified individual.

Cash runway extending into the fourth quarter of 2026 with no debt, funding current clinical programs through to their next data milestone Conference call scheduled for today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., Aug. 07, 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 second quarter ended June 30, 2025. “We continued to advance our clinical development portfolio and partnering initiatives during the second quarter of 2025,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “All of our activities are to support our core mission of exploiting the broad applicability of certepetide across a variety of advanced solid tumors and other difficult-to-treat indications. To this end, we recently announced positive preliminary results from the ASCEND and iLSTA trials, and we anticipate a number of additional data events through the remainder of 2025 and into 2026.” Dr. Mazzo added, “Our continued rigorous financial management allows us to reaffirm our projection that available cash will fund current operations into the fourth quarter of 2026, including all active clinical studies through to their next data milestone.” Development Portfolio Highlights Certepetide as a treatment for solid tumors in combination with other anti-cancer agents Certepetide (formerly LSTA1), a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug 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 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. As recently announced, preliminary 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, was presented at the ESMO Gastrointestinal Cancers (“ESMO-GI”) Congress on July 2, 2025. The preliminary Cohort B data demonstrate a positive signal in progression-free survival and objective response rate observed in the certepetide-treated group compared to the placebo-treated group, indicating that the addition of two doses of certepetide (Cohort B regimen) to SoC resulted in a clinically meaningful treatment effect and an attractive safety profile. Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available. 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 fourth quarter of 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 readout 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. As recently announced, enrollment in this study has been completed. Updated interim analyses from the iLSTA trial, presented at the ESMO-GI Congress on July 3, 2025, show compelling new preliminary data for certepetide. Consistent with earlier preliminary findings from the 2025 ASCO-GI meeting, the data reinforce certepetide’s potential to enhance immunotherapy effectiveness by provoking significant RECIST responses and improving overall response and disease control rates. Final data and key findings from this study are anticipated in the first quarter of 2026. 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 expected in 2026. Lisata entered into a research license with Catalent, Inc. (“Catalent”), to preclinically evaluate the efficacy of certepetide in combination with Catalent’s SMARTag® ADC dual payload technology platform for the treatment of various difficult-to-treat diseases. Additionally, Lisata has expanded its strategic collaboration with GATC Health Corp (“GATC”) to combine Lisata’s drug development expertise with GATC’s AI-powered Multiomics Advanced Technology™ platform to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination therapies. Lisata recently announced that the United States Patent and Trademark Office (“USPTO”) issued the Company a new composition of matter patent for certepetide (U.S. Patent No. 12,351,653), which extends its patent protection until March 2040, with potential for further extensions. The patent grants Lisata exclusive rights to the drug itself, preventing others from manufacturing or selling certepetide. The patent’s claims cover certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumors. Second Quarter 2025 Financial Highlights Revenue For the three months ended June 30, 2025, revenue totaled $70 thousand in connection with an upfront license fee related to the Research License Agreement with Catalent, Inc. We did not have any revenue for the three months ended June 30, 2024. Operating Expenses For the three months ended June 30, 2025, operating expenses totaled $4.9 million, compared to $5.5 million for the three months ended June 30, 2024, representing a decrease of $0.6 million or 10.6%. Research and development expenses were approximately $2.3 million for the three months ended June 30, 2025, compared to $2.6 million for the three 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 our Phase 2a BOLSTER trial and lower spend on chemistry, manufacturing and controls. General and administrative expenses were approximately $2.7 million for the three months ended June 30, 2025, compared to $2.9 million for the three 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. Overall, net losses were $4.7 million for the three months ended June 30, 2025, compared to $5.0 million for the three months ended June 30, 2024. Balance Sheet Highlights As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $22.0 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the fourth quarter of 2026. Conference Call Information Lisata will hold a live conference call today, August 7, 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 fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide’s mechanism of action, please view our informative 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 solid tumors; our beliefs about the potential uses and benefits of certepetide; the potential of the collaboration with Catalent to develop new treatment options; the expected expiration of our patents for certepetide; our ability to obtain patent term extension on our U.S. composition of matter patent; 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 preliminary data 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: [email protected] Media: ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: [email protected] - Tables to Follow – This press release was published by a CLEAR® Verified individual.

BASKING RIDGE, N.J., July 31, 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, today announced that the Company will report its financial results for the second quarter ended June 30, 2025, on Thursday, August 7, 2025, after the close of trading and will host a conference call at 4:30 p.m. Eastern time. 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 fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative short film. For more information on the Company, please visit www.lisata.com. Contact: Investors: Lisata Therapeutics John Menditto Vice President, Investor Relations and Corporate Communications Phone: 908-842-0084 Email: [email protected] Media: ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: [email protected] This press release was published by a CLEAR® Verified individual.

ASCEND comprises two dosing regimens of certepetide evaluated in two separate study arms enrolled sequentially Positive signal in progression-free survival and objective response rate observed in certepetide-treated group compared to placebo-treated group Cohort B data corroborate Cohort A data indicating certepetide has a treatment effect and an attractive safety profile Full study data from both cohorts expected later this year BARCELONA, Spain, June 26, 2025 (GLOBE NEWSWIRE) -- The Australasian Gastro-Intestinal Trials Group (“AGITG”), the NHMRC Clinical Trials Centre at the University of Sydney, and Lisata Therapeutics, Inc (“Lisata”, Nasdaq: LSTA), today announced promising positive preliminary Cohort B data from the ASCEND Phase 2b trial (NCT05042128) in metastatic pancreatic cancer, with AGITG sponsoring the study and Lisata providing funding. Dr. Andrew Dean, Study Chair, is scheduled to present these findings at the European Society for Medical Oncology (“ESMO”) Gastrointestinal Cancers Congress in Barcelona, Spain, on 2 July, 2025. The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care (“SoC”) gemcitabine and nab-paclitaxel vs SoC plus certepetide or placebo in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Participants were enrolled from 24 sites across Australia and Aotearoa New Zealand from May 2022 to December 2023. The study comprises two sequentially enrolled dosing regimens of either certepetide or placebo in combination with SoC. Cohort A employed one 3.2 mg/kg dose of certepetide administered as an IV push over 1 minute immediately after the infusion of gemcitabine and before the infusion of nab-paclitaxel. Cohort B mimicked the dosing regimen of Cohort A; however, it employed an additional dose of certepetide or placebo administered 4 hours after the initial dose. As announced in January of this year, preliminary Cohort A data was presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. Those data showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group. The preliminary data from Cohort B demonstrate a six-month progression-free survival (“6MPFS”) of 60.8% for the certepetide-treated group, whereas the 6MPFS in the placebo-treated group was 25%. Median progression-free survival (“mPFS”) was 7.5 months for the certepetide-treated group and 4.7 months for the placebo-treated group. Objective response rate (“ORR”) was 45.2% for the certepetide-treated group and 19% for the placebo-treated group. Median overall survival (“mOS”) was 10.32 months for the certepetide-treated group compared to 9.23 months for the placebo-treated group. A comparison of data from Cohort A and Cohort B indicates that the addition of two doses of certepetide (Cohort B regimen) to SoC chemotherapy resulted in a clinically meaningful improvement in both PFS and ORR for patients with mPDAC. These clinically significant findings provide compelling support for the continued and expedited investigation of certepetide as a novel therapeutic agent for the treatment of metastatic pancreatic cancer. Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available. “We are pleased with the promising Cohort B data of the ASCEND trial. These data, taken with those previously reported for Cohort A, reinforce our confidence in the therapeutic promise of certepetide. Along with its attractive safety profile, we continue to believe that certepetide has the potential to transform the treatment landscape for mPDAC and many other devastating solid tumors”, stated David J. Mazzo, PhD, President and Chief Executive Officer of Lisata. Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. In Australia, pancreatic cancer is the 3rd leading cause of cancer-related deaths2. With a five-year survival rate of just 13%, there is a considerable need for new treatment options. Dr. Dean commented, “The data from ASCEND provides us with critical new knowledge that will significantly enhance our understanding of how to optimally treat patients battling pancreatic cancer. We are excited by the evidence of certepetide’s therapeutic effect and encourage the continued development of this potentially treatment paradigm-changing compound.” We thank the Gut Cancer Foundation for providing funding for trial sites in Aotearoa New Zealand. 1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63. 2. Australian Institute of Health and Welfare (2024) Cancer data in Australia, AIHW, Australian Government, accessed 13 May 2025. About Certepetide Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including 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 test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. 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 (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). 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 fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative short film. For more information on the Company, please visit www.lisata.com. About the Australasian Gastro-Intestinal Trials Group (AGITG) The AGITG is a multi-disciplinary collaborative group that undertakes patient-centric research to advance medical care and practice in the treatment of gastro-intestinal cancer. Since 1991, the AGITG has led 90 GI cancer research studies, enrolling 9,900 patients across 287 sites worldwide. Learn more. About the NHMRC Clinical Trials Centre, University of Sydney The NHMRC Clinical Trials Centre is a flagship research centre at the University of Sydney that designs and coordinates clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. Over the past 35 years the NHMRC Clinical Trials Centre has co-led more than 150 clinicals trials involving over 100,000 patients which have changed global clinical practice. It also undertakes work in health economics, biostatistics, systematic reviews and biomarker research that can help inform healthcare providers about best practice. Learn more. Forward-Looking Statements (Lisata related) 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 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 preliminary data 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: Lisata Therapeutics (Investors): John Menditto Vice President, Investor Relations and Corporate Communications Email: [email protected] Phone: 908-842-0084 Lisata Therapeutics (Media): ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: [email protected] AGITG Erin Burgess, Head of Communications Email: [email protected] Mobile: 0402 152 592 NHMRC CTC, University of Sydney University of Sydney Media Office Email: [email protected] This press release was published by a CLEAR® Verified individual.

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 $5.8 million, compared to $6.6 million for the three months ended March 31, 2024, representing a decrease of $0.8 million or 11.4%. Research and development expenses were approximately $2.6 million for the three months ended March 31, 2025, compared to $3.2 million for the three months ended March 31, 2024, representing a decrease of $0.6 million or 19.7%. This was primarily due to a reduction in clinical research organization expenses and site expenses associated with our Phase 2a proof-of-concept Bolster trial and lower spend on chemistry, manufacturing and controls. General and administrative expenses were approximately $3.2 million for the three months ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2024, representing a decrease of approximately $0.1 million or 3.4%. This was primarily due to one-off settlement costs in the prior year partially offset by an increase in consulting expenses and severance costs in the current year. Overall, net losses were $4.7 million for the three months ended March 31, 2025, compared to $5.4 million for the three months ended March 31, 2024. Balance Sheet Highlights As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities of approximately $25.8 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the third quarter of 2026. 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: [email protected] Media: ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: [email protected] This press release was published by a CLEAR® Verified individual.

Release Date: May 08, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lisata Therapeutics Inc (NASDAQ:LSTA) reported a decrease in operating expenses by 11.4% year-over-year, indicating effective cost management. The company has made significant progress in advancing its clinical development portfolio, particularly with the novel product candidate certepatide targeting solid tumors. Preliminary results from the Ascend trial and Ilia trial data presented at the 2025 ASCO GI symposium showed promising potential for certepatide. Lisata Therapeutics Inc (NASDAQ:LSTA) has secured multiple special designations from both the FDA and EMA for certepatide, enhancing its regulatory standing. The company has established several collaborations to explore new strategic development opportunities for certepatide, including partnerships with Belo Therapeutics and Catalan. Despite progress, Lisata Therapeutics Inc (NASDAQ:LSTA) faces persistent market headwinds for small-cap healthcare companies. The company's net losses were $4.7 million for the first quarter of 2025, although this is an improvement from the previous year. Enrollment completion for certain trials, such as the glioblastoma multiforme study, is not expected until 2026, indicating long timelines for some projects. The company has limited control over study timelines for investigator-initiated trials, which may affect expectations and outcomes. Lisata Therapeutics Inc (NASDAQ:LSTA) is operating in a challenging financial environment, which necessitates careful management of resources and may impact the pace of development. Warning! GuruFocus has detected 2 Warning Signs with LSTA. Q: Regarding the Bolster study, specifically the second line of cholangiocarcinoma cohort, now that target enrollment is capped at about half of what was initially targeted, will this impact the regulatory path forward or the kind of data needed to move forward? A: Dr. David Mazzo, CEO: The Bolster trial is a phase 2A proof of concept trial, not powered to any specific endpoint. The number of patients enrolled is chosen to be indicative of trends. With 20 patients and a control in both arms, we can determine therapeutic effects with confidence. Curtailing enrollment allows for faster data outcomes and saves costs in challenging financial times. Q: Regarding the Ascend presentation and timing, how detailed will the data analysis be? Will the audience have a strong impression of the data or walk away with questions? A: Dr. David Mazzo, CEO: The cohort B data will be presented in July at ESO GI, providing definitive data on major endpoints like overall survival. The main results from both cohorts will be interpretable after this presentation, although some statistical analysis will follow to determine if data from both cohorts can be combined. Q: Clarification on Chilu's phase 2 data timeline, as it seems shorter than the previously mentioned 12 to 18 months after enrollment completion. A: Dr. David Mazzo, CEO: Chilu is on the innovation pathway in China, which requires being the first to approve the product. This drives their fast-paced strategy. They may move quickly based on corroborative results to maximize benefits, even if it means taking risks by advancing to phase 3 sooner. Q: Is there any activity regarding having manufacturing for trials done by big pharma manufacturers who could potentially be licensees? A: Dr. David Mazzo, CEO: Big pharma typically doesn't have excess capacity and doesn't function as contract manufacturers unless they've signed a deal or acquired the product. Switching products in multi-purpose facilities is costly and time-consuming, so they wouldn't manufacture small clinical supplies. Q: How are you progressing with potential partnerships in the endometriosis field? A: Dr. David Mazzo, CEO: Discussions are early, based on preliminary mouse study data. Most potential partners prefer clinically ready assets over pre-clinical programs, but discussions continue. Q: What is the level of activity regarding studies of tethered administration of certepetide? A: Dr. David Mazzo, CEO: We announced a collaboration with Catalan, where certepetide will be tethered to Catalan's Smart tag ADC platform. This is our first major step into covalently binding certepetide for delivery and therapeutic effect. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.