Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q1 2025 Earnings Call Transcript

Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q1 2025 Earnings Call Transcript May 8, 2025

John Menditto – VP of IR and Corporate Communications:

David Mazzo – President and CEO:

James Nisco – SVP of Finance and Treasury and Chief Accounting Officer:

Kristen Buck – EVP of R&D and Chief Medical Officer:

Operator: Welcome to the Lisata Therapeutics First Quarter 2025 Financial Results and Business Update Conference Call. Currently, all participants are in listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, May 8, 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.

John Menditto: Thank you, operator, and good afternoon, everyone. Welcome to Lisata’s first 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 first quarter 2025 financial results, which is under the investors and news section of the company website, along with a webcast replay of this call. If you have not received this news release or would like to be added to the company’s email distribution list, please subscribe to the email alerts on the website or email me at jmenditto@lisata to be added to the list.

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 10Q, 8K, and 10K, 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, May 8, 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. Mazzo. Dave?

David Mazzo: Thank you, John. Good afternoon, everyone. It’s a pleasure to be here again to provide an overview of Lisata’s recent business highlights, discuss our first quarter 2025 financial results, and give an update on the progress of our development programs. Building on an eventful 2024, we’ve maintained strong momentum into 2025 despite persistent market headwinds for small-cap healthcare companies. We continue to make significant progress advancing our clinical development portfolio for our novel product candidate Certepetide targeting solid tumors and other difficult to treat diseases. The ongoing accumulation of both preclinical data and especially clinical data supports our belief that Certepetide has the potential to become a cornerstone of a revised standard of care treatment regimen for advanced solid tumors of many types.

We were particularly encouraged by the preliminary results from both Cohort A of the ASCEND trial and the iLSTA trial data presented at the 2025 ASCO GI Symposium in January. These data reinforce both Certepetide’s potential and our overall development strategy. We anticipate that the next 12 to 18 months will be data-rich for Lisata with several key milestones on the horizon. We will continue to share our progress and key findings as they become available. Following the review of our financial results, Dr. Kristen Buck, our Chief Medical Officer and Head of Research and Development, will provide an update on our ongoing and planned clinical and preclinical programs, including timelines and key objectives. And 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?

James Nisco: Thanks, Dave. Good afternoon, all. I’m pleased to join you today to present a summary of our first quarter 2025 financial results, starting with operating expenses. 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. 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 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. With that, I will now turn the call over to Dr. Kristen Buck to provide an overview of the company’s development program. Kristen?

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 is focused on the development of its proprietary cyclic peptide product candidate, Certepetide, for the treatment of advanced solid tumors and other difficult-to-treat diseases. Certepetide is an investigational drug 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 own body’s 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 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 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. The trial is being conducted at 25 sites in Australia and New Zealand, sponsored by the Australasian Gastro-Intestinal Clinical Trials Group, or AGITG, in collaboration with the National Health and Medical Research Council Clinical Trial Center at the University of Sydney.

As mentioned on prior calls, the ASCEND trial is an investigator-initiated trial that Lisata inherited upon our acquisition of ASCEND Therapeutics. The original trial was designed with more of an academic nature, rather than one with commercial objectives, as was statistically powered based on a six-month progression-free survival primary endpoint. After the acquisition, Lisata collaborated with the AGITG to modify the trial to ensure it provided clinical outcomes that would best support the next steps in development of Certepetide from a regulatory perspective. As such, the ASCEND trial protocol was amended to include another cohort of patients, or 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 Cohort A and Cohort 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 delayed compared to Cohort A data by several months. 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, 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 intravenous doses of Certepetide or placebo, administered four hours apart in combination with standard of care, has been accepted for presentation at the 2025 ESMO Gastrointestinal Cancer Congress to be held during the first week of July.

Final analysis of both cohorts is planned to be available thereafter. The Bolster trial is our Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the United States evaluating Certepetide in combination with standard of care in first- and second-line cholangiocarcinoma. Enrollment was completed in first-line cholangiocarcinoma nearly six months ahead of plan, accelerating anticipated top-line data readout to mid-2025. Based on encouragement from multiple investigators involved in the trial, a second cohort was added evaluating Certepetide in subjects in second-line cholangiocarcinoma on top of standard of care. Although originally planned to recruit 40 patients, we recently took the decision to cap enrollment in this new arm at approximately 20 patients to allow for quicker data analysis and more efficient use of our capital.

CENDIFOX is a Phase 1b/2a 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. The 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 the three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 patients with oligometastatic colon cancer.

We are eagerly awaiting data from this investigator-initiated study and will share key findings when available. 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 mPDAC. Qilu recently reported that they completed enrollment in the study of 96 subjects. According to guidance from Qilu, data are expected in the next 12 to 18 months with a Phase 3 study planned to start thereafter. Based on the terms of the license, Qilu will be obligated to pay Lisata a $10 million milestone upon dosing of the first patient in their Phase 3 study. In collaboration with AstraZeneca in Australia and the funding sponsor of the iLSTA trial, WARPNINE, we are evaluating Certepetide in a Phase 1b/2a randomized placebo-controlled three-arm, single-blind, single-center, safety, early efficacy, and pharmacodynamic trial.

The iLSTA trial is being conducted in Australia combining Certepetide with the checkpoint inhibitor durvalumab with standard-of-care gemcitabine and nab-paclitaxel chemotherapy versus Certepetide in combination with standard-of-care that is no durvalumab versus standard-of-care alone in patients with locally advanced non-resectable pancreatic cancer. Promising preliminary results from the first 17 of 30 patients enrolled in the iLSTA trial were presented at the 2025 ASCO GI Symposium. This interim analysis suggests that Certepetide in combination with standard-of-care chemotherapy and immunotherapy improves treatment outcomes for this patient population while also provoking an increase in tumor-infiltrating lymphocytes in subjects with recessed response.

With more than 90% of patients enrolled, we remain confident that enrollment will be completed in the next two months. A study of Certepetide in combination with temozolomide in patients with glioblastoma multiforme, or GBM, has been initiated with several patients already enrolled and treated. This study is designed as a phase 2a double-blind placebo-controlled randomized proof-of-concept study evaluating Certepetide when added to standard-of-care temozolomide versus temozolomide alone and a matching Certepetide placebo in subjects with newly diagnosed glioblastoma multiforme. This actively enrolling study 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 Certepetide plus standard-of-care versus placebo plus standard-of-care.

Enrollment completion is now expected in 2026. FORTIFIDE is a conceptual phase 1b/2a double-blind placebo-controlled three-arm randomized study evaluating the safety, tolerability, and efficacy of a four-hour continuous infusion of Certepetide in combination with standard-of-care in patients with first-line pancreatic cancer. As part of the study, Lisata has engaged Haystack Oncology to use its MRD technology to measure circulating tumor DNA levels at multiple time points in patients through the study as an exploratory endpoint for analyzing the early therapeutic of Certepetide. Initiation of the study remains on hold as the company is investigating a potentially faster and more cost-effective alternative to achieving the study’s objective.

Additionally, Lisata has recently established several collaborations across oncology and other therapeutic areas to explore new strategic development opportunities for Certepetide. These include a partnership with Valo Therapeutics to investigate the benefits of combining Certepetide with Valo Therapeutics PeptiCRAd, a customizable oncolytic adenovirus platform technology, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma. Initial results from this collaboration are expected by early summer. Following results from an earlier preclinical study, Lisata entered into a global license agreement with Kuva Labs to explore the synergistic potential of Certepetide as a targeting and delivery agent for Kuva’s NanoMark imaging technology in solid tumors.

Kuva has communicated that it intends on commencing its imaging study in the first half of this year with results anticipated in early 2026. Lisata will provision Certepetide to Kuva for its clinical study via a clinical supply agreement. And recently announced, Lisata has entered into a research license with Catalent to evaluate in a preclinical setting the efficacy of Certepetide as a payload on Catalent’s SMARTag antibody drug conjugate dual payload technology platform for the treatment of difficult-to-treat diseases, including advanced solid tumors. Under the terms of the agreement, Catalent will assume full responsibility for all research and development expenses, and Lisata will provide consulting support. Beyond the clinical studies I’ve outlined, we are actively exploring additional opportunities to advance our development strategy, including progressing Certepetide in combination with gemcitabine and nab-paclitaxel into a global Phase 3 trial for the treatment of pancreatic cancer.

However, we remain focused on only initiating trials that can be funded through data with existing or guaranteed capital, and that can be executed within a reasonable period of time. As a reminder, several of the clinical trials I mentioned earlier are investigator-initiated trials, and as such, Lisata has limited control over study timelines and expectations may change or may be subject to change. That said, we are grateful to the investigators, and especially to the patients participating in Certepetide clinical trials around the world. For detailed information on each trial, please refer to the appendix of our corporate presentation on our website. The presentation also includes two slides illustrating the anticipated timeline and execution of key milestones and data readouts.

Dr. Mazzo highlighted that we anticipate a data rich 2025 and look forward to sharing these results. And with that, I will now turn the call back to Dave.

David Mazzo: Thanks, Kristen. Based on the excellence of execution of our Lisata team, we have started 2025 with another important collaboration and are poised to report data for many of our studies throughout the year. We and our partners firmly believe that Certepetide holds transformative potential for patients and significant long-term value for our respective shareholders, and we look forward to reporting on the progress toward realization of that potential on future calls. With that overview, Operator, we’re now ready to take questions.

Q&A Session

Operator: [Operator Instructions] Our first question comes from the line of Joe Pantginis of H.C. Wainwright. Your line is now open.

Unidentified Analyst: Hi. Good afternoon. This is Sarah on for Joe. Thanks for taking the question. My question is regarding the Bolster study, specifically the second line cholangiocarcinoma cohorts. Now that target enrollment, as you mentioned, is capped at about half of what you had initially targeted, I’m just wondering if you could provide some more color on whether this might impact the regulatory path forward or maybe the kind of data that you need to show to move forward. Thanks.

David Mazzo: Hey, Sarah. Thank you for that question. As Kristen described, the Bolster trial is a phase 2a proof-of-concept trial. It’s not powered to any specific endpoint, and therefore, the number of patients that are enrolled is really a number that we choose that we believe will be indicative of trends. And so what we’re really looking for in both the first line and second line cholangiocarcinoma study within Bolster is whether or not we’re seeing any therapeutic effect of Certepetide on the standard of care, non-patient outcomes. And with 20 patients, also with a control in both arms, we’ll be able to make those determinations, I think, with the same level of confidence that we would have with 40 patients in the second line.

But we really thought it was important to be able to get the data in both of those arms as soon as possible. And so by curtailing enrollment earlier, we’ll be able to get to final outcomes data for both arms faster, and we think that that’s important. And of course, in these financial times, which are a bit challenging, saving some money on enrollment of approximately half that study does not go without its benefits.

Unidentified Analyst: Okay, that’s helpful. Thanks.

Operator: One moment for our next question. Our next question comes from the line of Kemp Dolliver of Brookline Capital Market. Your line is now open.

Kemp Dolliver: Great, thank you. With regard to the ASCEND presentation and the timing, how deep will you be able to go in the data? I mean, you certainly would have top-line data and highlights of the supporting data, but how far along will you be in the data analysis such that the audience will have a strong impression of the data or walk away with a lot of questions because there are a lot of additional pieces to the puzzle?

David Mazzo: Hey, Kemp, thanks very much for joining in for that question. So basically, the plan of action for the reporting of ASCEND data, which is formulated by the sponsor of the study, which is the AGITG, is as follows. So the first part everybody knows. The Cohort A data, we call it preliminary data because basically they simply reported on the major endpoints, but there’s still some sub-analyses that needed to go on. Those data were presented at ASCO GI in January. The Cohort B data, which will be of the same level of detail as the Cohort A data was back in January, meaning essentially definitive data on the major endpoints, overall survival, PFS, et cetera, will be reported in the first week of July at ESMO GI. And what would remain would be a combination of the Cohort A and B data, some statistical analyses to determine whether or not A, first of all, you can combine the data either from both therapeutic arms or the placebo or individually, and then the results of that.

That’s an interesting study. And if we are able to combine the therapy arms, that will increase the power of the study a little bit. But really the main answers will be, I would say, interpretable after the July ESMO GI presentation, because at that point you’ll have the main results from both Cohort A and Cohort B.

Kemp Dolliver: Fabulous. Thank you. And I want to clarify the discussion around Qilu because the press release says the data, phase 2 data are expected in the near future. And we’ve talked in the past about it taking 12 to 18 months to get the data after they’ve completed enrollment. And my recollection is that it hasn’t been 12 to 18 months since they completed enrollment as a trial.

David Mazzo: That’s right, Kemp. So some of this is semantic, but I’ll preface everything that I’m about to say with the caveat that we have no control over the timeline that Qilu announces or actually follows, nor do we have any real control over the strategy that they’re pursuing in terms of timing. What we do know and what I think the audience should focus on is that they are on the innovation pathway in China, which is a special regulatory pathway, which provides multiple levels of benefits, including ultimately some commercial benefits. But one of the major requirements of obtaining those benefits is being the first country in the world to approve the product for which those benefits are requested. So in order for them to maximize or fully exploit their perceived value of Certepetide, they need to get it approved in China before it’s approved anywhere else.

I think that drives a lot of their decisions. That’s my interpretation. But as a result, they’re trying to move things along very, very fast. And most of what they do is essentially a confirmation of what we have done with our collaborators previously. And so they start off with a plan, but sometimes they cut it short because they’re getting the results that are corroborative and they need to move on more quickly. So I think that one could interpret this as they’re seeing enough of a trend from the data they already have from phase 2 to make the commitment to move on to phase 3. And they probably put that into a risk benefit equation to determine whether or not taking that risk and going faster was worth it in comparison to waiting and potentially losing the innovation pathway benefit.

I hope that’s clear.

Kemp Dolliver: That’s very helpful. Thank you.

David Mazzo: Thanks.

Operator: One moment for our next question. Our next question comes from the line of Pete Enderlin of MAZ Partners. Your line is now open.

Pete Enderlin: Hi, everybody. Thanks for taking my questions. You have been using a contract manufacturer for Certepatide for clinical trials. What about the possibility and is there any activity along those lines of having manufacturing for trials done by some big pharma manufacturers that would have that capability and could potentially be licensees?

David Mazzo: Well, thanks, first of all, for joining, Pete, and asking the question. And I think your question kind of, in some respects, puts the cart before the horse. Most big pharma have minimal excess capacity at this point in time. They manage their manufacturing capacity very closely because excess capacity is wasted money, and they don’t want to have that. And so, they balance external manufacturing with internal manufacturing, and they typically don’t function as a contract manufacturer for other products unless they’ve actually either already signed a deal on those products or licensed or acquired the product.

Pete Enderlin: Right, but of course, these would be small quantities. These would be very small quantities.

David Mazzo: Sorry, say that again, please.

Pete Enderlin: I said these would be very small quantities. It wouldn’t require them to allocate a large portion of their capacity.

David Mazzo: Well, no, they’d have to isolate a manufacturing train to make these things. And so, switching products actually takes, within a multipurpose facility, actually takes quite a lot of time and money because you have to clean the facility, decontaminate it, test it to demonstrate that you have no residuals, then bring the new process in, re-qualify the process, and then you can manufacture. So, you typically don’t switch back and forth. Multipurpose facilities typically take large chunks of time and devote them to products. They would never manufacture small amounts for clinical supplies unless that was their business, and no big farmers are in that kind of business.

Pete Enderlin: Okay, fair enough.

David Mazzo: And they would charge us a fortune to do that.

Pete Enderlin: All right. Well, I thought I saw some comment that you might possibly do that, but maybe that wasn’t from you guys yourselves. Anyway, another question, if I could squeeze it in. How are you doing strategically in arranging potential partnerships in the endometriosis field?

David Mazzo: Well, discussions in the endometriosis field are very, very early because the only data we have are preliminary data from a mouse study. That data was encouraging. It was done by one of the foremost experts in the pathology of endometriosis, which is at the University of Cincinnati. But at this stage, we’re seeing who’s interested. And unfortunately, in this environment, most of the potential partners are more interested in clinically ready assets and not preclinical programs. But we continue to have discussions.

Pete Enderlin: Okay. And another one that I’ll probably strike out also is that in terms of, Certepetide being either tethered or co-administered, initially, of course, mostly co-administered, but what kind of level of activity behind the scenes is going on with regard to the possibility of studies of tethered administration?

David Mazzo: Well, we’ve actually announced one, which is the Catalent Research Collaboration. Certepetide will be tethered to Catalent’s SMARTag ADC platform. So that’s really the first major foray into covalently binding Certepetide 200 moieties for delivery and therapeutic effect.

Pete Enderlin: Okay. I didn’t realize it was actually covalent or whatever you call that. That’s very interesting.

David Mazzo: Yeah. Yeah.

Pete Enderlin: Okay. Thank you a lot.

David Mazzo: Thanks, Pete. Take care.

Operator: I am showing no further questions at this time. I would now like to turn it back to Dr. Mazzo for closing remarks.

David Mazzo: Okay. Well, again, thank you all for participating in today’s call. We remain grateful for your continued interest and support. Stay well. Have a good evening.

Operator: Thank you for your participation in today’s conference. This concludes the program. You may now disconnect.