Lisata Therapeutics Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: Lasada entered a research agreement with Catalent to explore certepatide as a payload in advanced antibody–drug conjugates and formed a strategic alliance with GATC Health to apply AI in new drug discovery.
  • Positive Sentiment: Preliminary data from the ASCEND and I LISTA trials showed encouraging signals in overall survival, progression-free survival, and objective response rates for certepatide, and the FDA agreed on key elements of a Phase III protocol.
  • Neutral Sentiment: Second-quarter revenue was $70,000 from a Catalent license, operating expenses fell 10.6% to $4.9 million, net loss narrowed to $4.7 million, and cash resources of approximately $22 million are expected to fund operations into 2026.
  • Positive Sentiment: The U.S. Patent and Trademark Office granted a composition of matter patent for certepatide extending protection until March 2040, securing the drug’s core intellectual property.
  • Neutral Sentiment: Preparations for a global Phase III trial in metastatic pancreatic cancer are underway, with an anticipated enrollment of 650–900 patients and a design powered for a 0.75 hazard ratio, pending capital availability.
AI Generated. May Contain Errors.
Earnings Conference Call
Lisata Therapeutics Q2 2025
00:00 / 00:00

Transcript Sections

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Operator

Welcome to the Lisada Therapeutics Second Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, we will hold the q and a session. To ask a question at the please press 11 on your telephone. You will then hear an automated message advising a hand is raised.

Operator

As a reminder, this call is being recorded today, Thursday, 08/07/2025. I will now turn the call over to John Mendito, vice president of investor relations and Corporate Communications, Ashley Sada. Please go ahead, sir.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Thank you, operator, and good afternoon, everyone. For those of you who have been on Lesada's calls previously, you'll recognize that this is not John Mendito speaking, but this is actually the President and Chief Executive Officer, David Mazzo. Unfortunately, John is having technical difficulties and hasn't been able to join the call. And some of the other speakers have also been having some issues today. So we apologize for any inconsistent sound.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

And we hope that you'll be able to hear the webcast at a later date. Joining me from the management team are Doctor. Kristen Buck, the Executive Vice President of Research and Development and Chief Medical Officer, and James Nisko, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter twenty twenty five 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 this news release or if you would like to be added to the company's email distribution list, please subscribe to email alerts on the company website or email John Mendito at jmendittolessada dot com to be added.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Before we begin, I will 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 LASADA. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10 Q, eight 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, 08/07/2025. Lasada Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. I will now continue with my prepared remarks.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

And it, of course, is a pleasure to provide you with the latest update of Losada's recent business highlights, discuss our second quarter twenty twenty five financial results, and give a report on the progress of our development programs. Year to date, LASADA has executed on and achieved a number of impactful clinical and corporate milestones, with many of those coming since the start of the second quarter. On the business front, we signed a research agreement with Catalent exploring synergies between cerdepatide and their advanced antibody drug conjugate platform. And we formed a strategic alliance with GATC Health, employing their MAT artificial intelligence platform as a potential source of new drug development candidates, either alone or in combination with certepatide. Importantly, we recently announced preliminary results from both the ASCEND and I listed trials that were particularly encouraging, clearly validating cirtepatide's promise and our overall development approach.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

We continue to anticipate that the next twelve months will be a data rich period for LASADA with several key milestones on the horizon. And following the review of our financial results, Doctor. Kristin Buck, our Chief Medical Officer and Head of R and D, will provide an update on our ongoing and planned clinical studies, including timelines and key objectives. And with that, I will now turn the call over to James Nisko, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?

James Nisco
James Nisco
SVP, Finance, Treasury & Chief Accounting Officer at Lisata Therapeutics

Thanks, Dave. Good afternoon, I'm pleased to join you today to present a summary of our second quarter twenty twenty five financial results, starting with revenue. For the three months ended 06/30/2025, revenue totaled $70,000 in connection with an upfront licensee related to a research license agreement with Catalent Inc. We did not have any revenue for the three months ended 06/30/2024. Next, a review of our operating expenses.

James Nisco
James Nisco
SVP, Finance, Treasury & Chief Accounting Officer at Lisata Therapeutics

For the three months ended 06/30/2025, operating expenses totaled $4,900,000 compared to $5,500,000 for the three months ended 06/30/2024, representing a decrease of $600,000 or 10.6%. Research and development expenses were approximately $2,300,000 for the three months ended 06/30/2025, compared to $2,600,000 for the three months ended 06/30/2024, representing a decrease of $300,000 or 13.4%. This was primarily due to a reduction in patient treatment costs and clinical research organization expenses associated with our Phase IIa bolster trial and lower spend on chemistry manufacturing and controls. General and administrative expenses were approximately $2,700,000 for the three months ended 06/30/2025, compared to $2,900,000 for the three months ended 06/30/2024, representing a decrease of $200,000 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.

James Nisco
James Nisco
SVP, Finance, Treasury & Chief Accounting Officer at Lisata Therapeutics

Overall, net losses were $4,700,000 for the three months ended 06/30/2025, compared to $5,000,000 for the three months ended 06/30/2024. It is noteworthy that we continue to make progress according to our plans for our R and 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 06/30/2025, we had cash, cash equivalents and marketable securities of approximately 22,000,000 Based on its existing and planned activities, the company believes available funds will support current operations into the 2026. With that, I will now turn the call over to Doctor.

James Nisco
James Nisco
SVP, Finance, Treasury & Chief Accounting Officer at Lisata Therapeutics

Kristen Buck to provide an overview of the company's development programs. Kristen?

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

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, LASADA is focused on the development of its proprietary cyclic internalizing RGD peptide product candidate, certepatide, for the treatment of advanced solid tumors and other difficult to treat diseases. Certepatide 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, Certified 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.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

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 a regulatory front, cerdepatide has secured multiple special designations from both the FDA and EMA, all of which are 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 certepatide 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 and is sponsored by the Australasian Gastrointestinal Cancers Trial Group, or AGITG, in collaboration with the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

As I 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 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. However, after the acquisition, LASADA collaborated with the AGITG to modify the trial to ensure it provided clinical outcomes that would best support the next steps in 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, but it was to evaluate an additional certepatide dosing regimen.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

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 the trial's initiation, data from cohort B are being generated sequentially following cohort A data. Cohort A with ninety five patients receiving a single IV dose of cetepatide or placebo in combination with standard of care completed enrollment in the 2023. As announced in January, preliminary cohort data was presented at the twenty twenty five ASCO GI Symposium, which showed a positive trend in overall survival, including four complete responses in the certepatide treated group compared to none in the placebo treated group. And more recently, preliminary data from cohort B, with sixty three patients receiving two IV doses of certepatide, three point two milligrams per kilogram, or placebo administered four hours apart in combination with standard of care were presented at the ESMO Gastrointestinal Cancers Congress on 07/02/2025.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

These data showed a positive signal in both progression free survival and objective response rate in the certepatide treated group compared to the placebo treated group, indicating that the two dose regimen resulted in a clinically meaningful treatment effect and an attractive safety profile. Final data and key findings from both cohorts are anticipated for later this year. Furthermore, we have concluded an end of phase two discussion with the FDA, and we have agreement from the FDA on the fundamental aspects of an acceptable phase three protocol, including the dose, dosing regimen, blinding and primary endpoints. Based on that protocol, we have already begun preparation for trial initiation with capital acquisition to support the trial being the gating factor. The bolster trial is our own phase two, a double blind placebo controlled multicenter randomized trial in The United States, evaluating certepatide in combination with standard of care in first and second line cholangiocarcinoma.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

Enrollment was completed in the first line cholangiocarcinoma arm nearly six months ahead of plan, accelerating anticipated top line data readout to the 2025. Based on encouragement from multiple investigators involved in the trial, a second cohort was added, evaluating certepatide 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 a more efficient use of our capital. It should be noted that this is an exploratory trial that is not statistically powered, so we believe that the reduced number of patients in the second line arm will still be sufficient to determine if there is a treatment effect signal. Dendifox is a phase 1b2a open label trial in The United States evaluating certepatide in combination with neoadjuvant fulphironox based therapies in pancreatic, colon, and appendiceal cancers.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

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 sixty six patients enrolled, fifty met these criteria and were treated with cerdepatide across three cohorts, including twenty four with resectable or borderline resectable pancreatic cancer, fifteen with high grade colon or appendiceal cancer and peritoneal metastases, and eleven 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 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.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

Chilu recently reported that it completed enrollment in the study of 96 subjects. According to guidance from Chilu, data are expected in the next twelve to eighteen months with a phase three study planned to start thereafter. Based on the terms of the license, Chi Lu will be obligated to pay Lesata a $10,000,000 milestone upon dosing of the first patient in their phase three study. In collaboration with AstraZeneca in Australia, and the funding sponsor of the I LISTA trial, WARP nine, we are evaluating certepatide in a phase 1b2a randomized placebo controlled three arm single blind single center safety, early efficacy, and pharmacodynamic trial. The trial is being conducted in Australia combining certepatide with the checkpoint inhibitor durvalumab plus standard of care gemcitabine and nab paclitaxel chemotherapy versus certepatide in combination with standard of care that is no durvalumab in that arm versus standard of care alone in patients with locally advanced non resectable pancreatic cancer.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

As recently announced, enrollment in the EYLISTTA study is complete. An updated interim analysis presented at the ESMO GI Congress on 07/03/2025, reveals compelling new preliminary data for Certified. These data are consistent with earlier findings from the twenty twenty five ASCO GI meeting, further reinforcing cerdepatide's potential to significantly 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 2026. A study of cirtepatide in combination with temozolomide in glioblastoma multiforme, or brain cancer, has been initiated with several patients already enrolled and treated.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

The study is designed as a Phase IIa double blind, placebo controlled, randomized, proof of concept study evaluating certepatide when added to standard of care temozolomide versus temozolomide alone and matching certepatide 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 now include a site in Lithuania. The study is targeted to enroll 30 patients with a two to one randomization certepatide plus standard of care versus placebo plus standard of care. The study is more than fifty percent enrolled with additional patients currently in screening. Enrollment completion is expected in 2026.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

Moving on now to exciting developments in recent collaborations and a significant intellectual property milestone. Recently, Lesata entered into a research license with Catalent to evaluate in a preclinical setting the efficacy of cerdepatide as a payload on Catalent's smart tag 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 has assumed full responsibility for all research and development expenses, and LASADA is providing consulting support. It is our belief that preliminary positive data from this collaboration could be the harbinger of a more extensive license agreement in the future. Additionally, we've established an evolving strategic collaboration with GATC Health.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

This partnership combines Lusada's drug development expertise with GATC's AI powered Multiomics Advanced Technology Platform to accelerate and optimize drug discovery. This includes analyzing certepatide for new indication targets, including some outside of oncology, as well as identifying effective combination therapies. Further strengthening our position, the United States Patent and Trademark Office issued a new composition of matter patent for cirtepatide, extending our protection until March 2040, with the potential for further extensions. This patent grants LASADA exclusive rights to the drug itself, preventing others from manufacturing or selling certepatide. The patent's claims cover certepatide's chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumors.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

Looking ahead, beyond the clinical studies I've mentioned, we are actively exploring additional opportunities to advance our development strategy, including progressing cirtepatide in combination with gemcitabine and nab paclitaxel in a global phase three trial for the treatment of metastatic pancreatic cancer. However, we remain focused only on 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 studies I mentioned are investigator initiated trials, meaning LoSATA has limited control over study timelines, and expectations may That be subject to said, we are incredibly grateful to the investigators and especially to the patients participating in certepatide clinical trials around the world. For detailed 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.

Kristen Buck
Kristen Buck
EVP - R&D & Chief Medical Officer at Lisata Therapeutics

With that, I will now turn the call back to Dave.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Thank you, Kristen. As we conclude, it's important to acknowledge that the excellence and dedication of our LASADA team remain the driving force behind our progress. Based on the positive clinical data that we have reported to date and the uniqueness of cerdepatide's mechanism of action, we continue to demonstrate the broad applicability of cerdepatide across a wide variety of advanced solid tumors and other difficult to treat indications with the goal of ultimately transforming the cancer treatment paradigm while realizing certepatide's full value. And with that overview, operator, we are now ready to take questions.

Operator

As a reminder, to ask a question, please press 11 on your telephone, and you will then hear an automated message advising you 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. And for your first question, it comes from the line of Joe Pantginis from H. C. Wainwright. Joe, your line is open. Please ask your question.

Analyst

Hi, this is Josh on for Joe. Thank you for the update. I just had a quick question about the ASCEND trial. So I was wondering if there's any additional insights you provide us at this time on what this Phase III protocol may look like?

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Well, at this stage, we've had already the end of phase 2B meeting with FDA. And we have a tacit agreement on the structure of an open label phase three trial. We anticipate it to have somewhere on the order of six fifty to nine hundred patients, depending upon how many dosing arms we include. At this stage, we're contemplating including a continuous infusion dosing arm along with a two dose of certepatide dosing arm for comparison. But in the end, the exact design and size will be determined by statistics which will power the trial at ninety percent and maintain a hazard ratio at 0.75.

Analyst

Perfect. Thank you so much.

Operator

Thank you. And one moment for your next question. And for your next question, it comes from the line of Will Heidel from Brookline Capital Markets. Your line is open. Please ask your question.

Will Hidell
Equity Research Associate at Brookline Capital Markets

Hey, thank you for taking the questions. Quick question about the spending. I noticed that it's gone down a bit. Do you expect spending to remain the same? I know you've extended the runway by a quarter.

Will Hidell
Equity Research Associate at Brookline Capital Markets

What What's your expectations on that over the next year?

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Well, it'll depend on when we initiate the phase three and also what the results of the BOLTAR trial indicate and then our plans to move the cholangiocarcinoma indications to later stage development, as well as the advancement of some of the other products that are now in preclinical evaluation. But if we were to make no other changes right now, then we would expect that you would see a modest decrease in spending over time as the ongoing clinical trials completely wrap up.

Will Hidell
Equity Research Associate at Brookline Capital Markets

Great. Thank you.

Operator

Thank you. And for our next question, it comes from the line of Pete Anderlin from MAZ Partners. Pete, your line is open. Please ask your question.

Peter Enderlin
Portfolio Manager at MAZ Partners

Thanks. Good afternoon. Had been talking about cash through the '6, and now you're extending that to the fourth quarter. And you just referred to lower expenses, but is it also possible that you are including in that projection any future license revenues or any other revenues like tax benefits or anything like that?

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

At this stage, the projections only include the anticipation of a very small final contribution of capital from the New Jersey sale of NOL program. Other than that, though, they do not contemplate any capital raises or any infusions. Of course, we'll be looking to do something probably later this year or early next year in order to fund future operations and future clinical trials. But the current projections do not include anything other than a small sale of New Jersey NOLs as part of the program next year.

Peter Enderlin
Portfolio Manager at MAZ Partners

Got it. And then Christian just mentioned the recent June patent the coverage extending through 02/1940. And you previously had talked more or less about pretty full broad coverage through 02/1930. So I'm wondering what changed in terms of the latest patent versus what was covered and all the other patents kind of put together.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Oh, well, the latest patent just recognized some specific intellectual property around the actual composition of matter of cirtepatide itself. And the composition of matter patents, Pete, are fundamental patents that are the most difficult to work around. And so with the granting of that patent and the extension of that patent life out into the 2040s, we feel that the intellectual property portfolio is now really ultimately secure.

Peter Enderlin
Portfolio Manager at MAZ Partners

Great. And if I could venture one more, Dave. Would you be willing to give some kind of a comment on the regulatory resistance of the FDA, which we all know about, versus what it's like in China, and that's of course relevant for the approval of the payment of large sum once you get the first patient enrolled over there, but they get it. But I mean in terms of time and difficulty and the amount of information that's required, can you compare The US versus China in any way?

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

It's hard to do so, Pete, not being a Chinese company. Chinese companies have special relationships with their regulatory authorities, and there's a lot of politics that goes into that. So I really can't compare and contrast between the two. All I will say is that the FDA has been very clear about their guidances for the development of cancer products. And we continue to work with them to find the most expeditious way to move our products forward.

Peter Enderlin
Portfolio Manager at MAZ Partners

Fair enough. Okay, thank you.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Thanks.

Operator

Thank you. And this concludes the question and answer session. I will now turn the call back to Doctor. Mazzo for closing remarks.

David Mazzo
David Mazzo
President, CEO & Director at Lisata Therapeutics

Well, again, thank you all for participating in today's call. We remain grateful for your continued interest and support. Stay well, and have a good evening.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Executives
    • David Mazzo
      David Mazzo
      President, CEO & Director
    • James Nisco
      James Nisco
      SVP, Finance, Treasury & Chief Accounting Officer
    • Kristen Buck
      Kristen Buck
      EVP - R&D & Chief Medical Officer
Analysts
    • Analyst
    • Will Hidell
      Equity Research Associate at Brookline Capital Markets
    • Peter Enderlin
      Portfolio Manager at MAZ Partners
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