Welcome to the Lisata Therapeutics Third Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, November 6, 2025. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

Thank you, operator, and good 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 e-mail distribution list, please subscribe to the e-mail alerts on the company website or e-mail 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 6, 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, and good afternoon, everyone. It's my pleasure to provide the latest update of Lisata's 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 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 CENDIFOX trial, adding further corroboration to our expectations of the positive impact of certepetide as part of various anticancer treatment regimens. On the business development front, we entered into a strategic alliance with GATC Health to use their multiomics 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 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 time lines 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 3 months ended September 30, 2025, operating expenses totaled $4.4 million compared to $5.3 million for the 3 months ended September 30, 2024, representing a decrease of $0.9 million or 17.3%. Research and development expenses were approximately $2 million for the 3 months ended September 30, 2025, compared to $2.5 million for the 3 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 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 9 months ended September 30, 2025, BOLSTER trial costs are lower than prior year. General and administrative expenses were approximately $2.5 million for the 3 months ended September 30, 2025, compared to $2.8 million for the 3 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 savings from the elimination of an employee position. Overall, net losses were $4.2 million for the 3 months ended September 30, 2025, compared to $4.9 million for the 3 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 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, 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 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. Certepetide 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, 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 the 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 Clinical Trials Group or AGITG, in collaboration with the National Health and Medical Research Council Clinical Trials Center at the University of Sydney. As we mentioned in the past, this investigator-initiated trial was inherited upon our acquisition of Cend Therapeutics. The original trial was designed with an academic bent rather than one with the…

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 noncancer indications, and I look forward to sharing our progress on future calls. With that overview, operator, we're now ready to take questions.

[Operator Instructions] Your first question comes from the line of Joe Pantginis with H.C. Wainwright. Lander Egaña-Gorroño: This is Lander on for Joe. So for CENDIFOX, when approximately should we expect the next Phase IIb data cut? And for the GBM trial, could you provide some color on the enrollment status for the target sample size?

Lander, thanks for joining and for asking the questions. On CENDIFOX, 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. 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?

As it relates to 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. So things are moving very well according to plan.

Your next question comes from the line of Robert Sassoon with Water Tower Research.

Just a couple of questions. Your cash flow runway to the first quarter of '27, what is that actually -- can you sort of run through what that really includes in terms of expenditures going into 2026?

Yes, sure. So thanks for the question. And 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.

Is there any sort of assumption of Phase III trial for ASCEND actually incorporated into those assumptions?

There is not.

Okay. And one more question for me. I mean you've come out with some pretty robust clinical data, a series of them over the past year. And 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?

Everything candidly. I think the problem is a confluence of negative forces that seem to be affecting lots of small cap companies, but it's 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 doesn't react. And I think that's partly because the macro environment is not favoring small-cap biotech these days. So there aren't quite a lot of buyers. We're also stuck in a difficult situation because many of our shareholders are -- treat their holdings in Lisata 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.

Next question comes from the line of Pete Enderlin with MAZ Partners.

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 #1 award of that type given at 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 so trivial, but the reason I'm asking that is -- and Dave, you said before that 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 doesn't -- hasn't responded. And 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 that 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 nonexclusive license, they would all be nonexclusive because each one would apply to a particular disease and a particular drug. And I know you're probably going to say it costs 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.

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 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.

Okay. Great. And just following up on a previous question. The -- I guess the burn rate looks like it will be roughly $3 million per quarter for the next 5 quarters. Is it going to be fairly level over that period of time?

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 ultimately generates values 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, et cetera, that are non-dilutive. And of course, we'll give those priority.

Next question comes from the line of Kemp Dolliver with Brookline Capital Markets.

With the final analysis of the ASCEND data coming relatively soon, could you talk about your thinking for the next steps because as everybody on this call knows you need to raise a substantial amount of money to fund the Phase III. And there's some orchestration that goes on to get that done. And so 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. So 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. 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 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 III, 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 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.

Okay. And to be clear, this would be along the line -- predominantly along the lines of what it would be a pharma partner who would take an indication -- this indication may be other indications in order to move the company forward?

That's likely the structure of a big pharma deal.

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.