Welcome to the Lisata Therapeutics Q3 2025 Financial Results and Business Update Conference Call. Currently, all participants are in listen-only mode. Following management-prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star, one on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded today, Thursday, November 6th, 2025. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communication at Lisata. Please go ahead, sir. Thank you, operator. G ood afternoon, everyone. Welcome to Lisata's Third Quarter 2025 Conference Call, to discuss our financial results and to provide a business update. Joining me today from our management team are 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'd 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 jmenditto@lisata.com to be added, sorry. Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, its Forms 10-Q, 8-K, and 10-K, 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 6th, 2025. Lisata Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. David Mazzo. Dave. Thank you, John. G ood afternoon, everyone. It's my pleasure to provide the latest update of Lisata's recent business highlights, discuss our Q3 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 achieved several development milestones involving certepetide, including the announcement of encouraging preliminary results from multiple studies, including the ASCEND trial, the iLSTA trial, and the Sendafox trial, adding further corroboration to our expectations of the positive impact of certepetide as part of various anti-cancer treatment regimens. On the business development front, we entered into a strategic alliance with GATC Health, to use their Multinomics Advanced Technology, a rtificial intelligence drug discovery platform to identify product candidates for development. We also executed a non-exclusive global license agreement with Catalent, in which Catalent gains access to certepetide and its analogs for use as a payload for their SMARTag ADC technology platform. We continue to anticipate that the next several quarters will be a data and transaction-rich period for Lisata, 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, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James. Thanks, Dave. Good afternoon, all. 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 30th, 2025, operating expenses totaled $4.4 million, compared to $5.3 million for the three months ended September 30th, 2024, r epresenting a decrease of $0.9 million or 17.3%. Research and development expenses were approximately $2 million for the three months ended September 30th, 2025, c ompared to $2.5 million for the three months ended September 30th, 2024, r epresenting 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 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 30th, 2025, BOLSTER trial costs are lower than prior year. General and administrative expenses were approximately $2.5 million for the three months ended September 30th, 2025, compared to $2.8 million for the three months ended September 30th, 2024, representing a decrease of $0.3 million 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 30th, 2025, compared to $4.9 million for the three months ended September 30th, 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 30th, 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 the first quarter of 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. Thank you, James. G ood 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 is focused on the development of its proprietary cyclic internalizing RGD peptide product candidate, certepetide, for the treatment of advanced solid tumors and other difficult-to-treat diseases. C ertepetide is 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. In addition, certepetide 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 certepetide '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 a regulatory front, certepetide 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 IIb, 158-patient, double-blind, randomized, placebo-controlled clinical trial evaluating certepetide, in combination with standard- of- care gemcitabine and nab-paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, or mPDAC. Patient recruitment was conducted at 25 sites in Australia and New Zealand, and is sponsored by the Australasian Gastrointestinal Trials Group or AGITG, in collaboration with the National Health and Medical Research Council Clinical Trials Centre 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 bent 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 anti-cancer drug. After the acquisition, Lisata collaborated with the AGITG to modify the trial to ensure it measured clinical endpoints that would best support the next steps in development of certepetide 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 certepetide 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 certepetide or placebo in combination with standard of care, completed enrollment in the third quarter of 2023. As announced in January of this year, preliminary cohort A data was presented at the 2025 ASCO GI Symposium, which showed a positive trend in overall survival in the certepetide plus standard of care chemotherapy group, including four complete responses in this group. compared to none in the standar- of- care plus placebo-treated group. Most recently, preliminary data from cohort B with 63 patients receiving two intravenous doses of certepetide 3.2 mg per kilogram, or placebo administered four hours apart in combination with standard- of- care chemotherapy, were presented at the ESMO Gastrointestinal Cancers Congress on July 2nd, 2025. These data showed a positive trend in progression-free survival, overall survival, and objective response rate in the certepetide plus standard- of- care treatment group, compared to the standard of care plus placebo-treated group. Another complete response was also noted in the certepetide plus standard of care treated group, while none were observed in the standard of care plus placebo group. Additionally, full 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 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 the first quarter of 2026. As we have previously announced, we have completed an end-of-phase IIB 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 BOLSTER trial is our phase IIA double-blind placebo-controlled multi-center randomized trial in the United States, evaluating certepetide 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 the fourth quarter of 2025. Based on encouragement from multiple investigators involved in the trial, a second cohort was added, evaluating certepetide 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 Sendafox trial is a phase IA/IIA open-label trial in the United States, 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. 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 certepetide 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 of 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% 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 immunocold to immunohot, B y 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 Sendafox trial are anticipated in the coming months. 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 running a parallel development program for certepetide, in combination with gemcitabine and nab-paclitaxel as a treatment for metastatic pancreatic cancer. Qilu previously reported that they completed enrollment in the study of 96 subjects. However, we still await data from the study to be shared. Also, according to guidance last received from Qilu, data are expected in the next 12-18 months, and we anticipate ongoing dialogue to continue related to potential next steps in their development plan. The iLISTA trial is a phase Ib/IIa randomized placebo-controlled three-arm, single-blind, single-center trial evaluating the safety, early efficacy, and pharmacodynamics of certepetide 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 9, combining certepetide with the checkpoint inhibitor durvalumab plus standard of care, gemcitabine and nab-paclitaxel chemotherapy versus certepetide in combination with standard of care chemotherapy without durvalumab, versus standard of care alone. As recently announced, enrollment in the iLISTA study is complete. An updated interim analysis presented at ESMO GI Congress on July 3rd, 2025, revealed compelling positive preliminary data for certepetide. These data are consistent with earlier findings from the 2025 ASCO GI meeting, further reinforcing certepetide 's potential to significantly enhance immunotherapy effectiveness, by provoking significant recessed responses, improving overall response and disease control rates. Final data and key findings from this study are anticipated in the first quarter of 2026. A study of certepetide in combination with temozolomide in patients with glioblastoma multiforme or GBM, brain cancer has been initiated with many patients already enrolled and treated. This study is designed as a phase IIA double-blind placebo-controlled randomized proof-of-concept study evaluating certepetide, when added to standard of care temozolomide versus temozolomide alone, and matching certepetide 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 certepetide 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 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 certepetide 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 developments and achievements. As Dave mentioned earlier, Lisata and Catalent entered in a non-exclusive license agreement that grants Catalent global rights to evaluate certepetide and its analogues, for use as SMARTag 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, c ompelling positive data from Catalent's preclinical study showed both improved tumor- selective penetration and enhanced efficacy, further highlighting certepetide 's strong potential to significantly improve the targeting and overall effectiveness of ADCs and advanced solid tumors. Additionally, we've established a strategic alliance with GATC Health. This partnership combines Lisata's drug development expertise with GATC's AI-powered Multiomics Advanced Technology platform, to accelerate and optimize drug discovery. This includes in silico assessment of certepetide 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 certepetide. 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 certepetide in July 2025, e xtending our protection until March 2040, with the potential for further extensions. The patent's claim covers certepetide '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. Thanks, Kristen. In summary, the past quarter has been active and fruitful, as we have both advanced the broad development of certepetide, while identifying means by which to expand and diversify Lisata's 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 o verview, o perator, we're now ready to take questions. Thank you. As a reminder, to ask a question, please press star, one on your telephone. 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 Pantgini with H.C. Wainwright. Your line is open. Hello, everyone. This is Lander on for Joe. Thanks for taking our questions. For Sendafox, when approximately should we expect the next phase IIB data cut? For the GBM trial, could you provide some color on the enrollment status for the target sample size? Thank you. Hi, Lander. Thanks for joining and for asking the questions. On Sendafox, unfortunately, we really can't 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. We will 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. W hat was your second question? The GBM trial enrollment status? Yes. As it relates to the GBM trial, as Kristen mentioned, we're completely on track with that. The target is to enroll 30 patients, and I would say that we're approximately 2/3 of the way through. Things are moving very well according to plan. Perfect, t hat's very helpful. Thank you so much. Thank you. Your next question comes from the line of Robert Sassoon with Water Tower Research. Your line is open. Thank you. Just a couple of questions. Your cash flow r unway to the first quarter of 2027, c an you sort of run through what that really includes in terms of expenditures going into 2026? Yeah, sure. Thanks for the question. James is on the line if we want to go into more detail. 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. Is there any sort of assumption of a phase III trial for SEND to actually incorporate into those assumptions? There is not. Okay. One more question from me. I mean, you've come out with some pretty robust clinical data, a series of them over the past year. Your share price has not really reacted to it in the way that one would expect for that type of data. What do you think the investors are missing? Oh, everything, candidly. I think the problem is a confluence of negative forces that seem to be affecting lots of small-cap companies. It is especially frustrating for Lisata, 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 does not react. I think that is partly because the macro environment is not favoring small-cap biotech these days, so there are not quite a lot of buyers. We are also stuck in a difficult situation, because many of our shareholders treat their holdings in Lisata as a venture capitalist might. In other words, they have made their purchases quite a while ago and they' re holding for the long run, so they do not trade. 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. 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. 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. W e've demonstrated now that it can be used very broadly across a number of different types of cancers in a variety of different combinations. Okay, T hank you for that answer. That sounds very plausible. I'll jump back into the queue. Thank you. Next question comes from the line of Pete Enderlin with MAZ Partners. Your line is open. Thank you. Hi, everybody. First, 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 a t this time? I think we can say that that's the only award with that title or name. Yes, Pete. Okay. I mean, it seems sort of trivial, but the reason I'm asking that is, Dave, you said before that potential licensees or partners want to see more clinical results. Also, of course, we've seen a lot of positive results recently, but somebody else said the stock hasn't responded. Given the broad application of certepetide 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 t hat you could use the ones that you've gotten, Catalent and the other for kind of referrals and therefore kind of beat the bushes for some additional licenses? Given that, for example, Catalent is a non-inclusive license, they would all be non-inclusive because each one would apply to a particular disease and a particular drug. 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. No. I think 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. We do not need to do that with external consultants. We do that with our internal staff who know the product extremely well. That' s exactly what we are doing on a regular basis. We' re building on the momentum of the previous non-exclusive licenses, and the interest that was shown in those deals to generate new interest and hopefully build a greater consortium of different licensees. Okay, g reat. Just following up on a previous question, I guess the burn rate, looks like it will be roughly $3 million per quarter for the next five quarters. Is it going to be fairly level over that period of time? Let me put it this way, and listen carefully to the way I state this, so I am not misquoting anyone, but I hope not. I actually hope it' s going to go up. 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 ultimately generates values for shareholders. Of course, to do that, we'll likely have to raise some capital to supplement our current balance sheet. That would be the plan. There are ways for capital to come in through licensing fees, etc., that are non-dilutive. Of course, we'll give those priority. Right. Okay, g reat. Thanks very much. Okay. Next question comes from the line of Kemp Dol liver with Brookline Capital Markets. Your line is open. Great. Thank you. With the final analysis of the SEND data coming relatively soon, could you talk about your thinking for the next steps? E verybody on this call knows you need to raise a substantial amount of money to fund a phase III. There's some orchestration that goes on to get that done. I'd like to know your thinking about the steps in the process you'll lay out to do so. Thanks, Kemp for the question, and actually the opportunity to be clear on what our plans are. Based upon the data that's been generated from the phase IIB trial, we've concluded internally that the drug deserves further development and that moving to phase III 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 III in a manner that would not be so overly dilutive to current shareholders as to be distasteful. We are working, much to Pete's suggestion, the previous questioner, working to find licensees and partners who will be willing to b ear the brunt of that funding, or at least contribute in an equal manner 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 IIII, including completing activities on the CMC sIde, that would have us poised for phase III production and NDA validation, lot production, having the end of phase IIB meeting with FDA to discuss and agree on a protocol. 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. Okay. T o be clear, this would be predominantly along the lines of what, i t would be a pharma partner who would take this indication, maybe other indications i n order to move the company forward? That' s likely the structure of a pharma deal. Thank you. Thanks, Kemp This concludes the question- and- answer session. I will now turn the call back over to Dr. Mazzo for closing remarks. Again, thank you all for participating in today's call. We remain grateful for your continued interest and support in Lisata. Stay well, and have a good evening. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.