Lisata Therapeutics, Inc. Price & Performance (LSTA)

Before we begin, I'll 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 Lisata. 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, 02/27/2025. LASATA 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 Doctor. Maso. Dave? Thank you, John, and good afternoon, everyone, to pleasure to be here again to provide an overview of Lasada's recent business highlights discuss our full year 2024 financial results, and give an update on the progress of our development programs. Over the course of 2024 and now into early twenty twenty five, we have advanced our development portfolio centered around our novel product candidate, zutepatide, for the treatment of advanced solid tumors and other difficult to treat diseases.

The ongoing accumulation of both preclinical data and early clinical data supports our belief that stratepatide has the potential to become an integral part of a revised standard of care treatment regimen for advanced solid tumors including pancreatic cancer, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer and melanoma.

We were particularly encouraged by the preliminary results from Cohort A of the ASCEND trial and the iListed trials presented at the twenty twenty five ASCO GIC These data will early provide further validation of cetepatide's potential in and reinforce our conviction that certepatide could become a critical component of future treatment regimens for these devastating cancers. We are working diligently to advance these studies and explore additional anticancer combinations and treatment strategies. Beyond oncology, we are also excited about the potential of certepatide in other therapeutic areas. We have initiated the preclinical investigation of Sertepatide as a potential therapeutic agent for the treatment of endometriosis the disease which affects hundreds of millions of women worldwide and for which there remains a pronounced unmet medical need. Looking ahead, we anticipate 2025 will be a data rich year We have several key milestones on the horizon and we'll share our progress and key findings as they become available. Following the review of our financial results, Doctor. Kristen Buck our Chief Medical Officer and Head of Research and Development, will provide a detailed update on our ongoing and planned clinical and preclinical programs including timelines and key objectives. With that, I will now turn the call over to James Misko, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. [indiscernible] Thanks, Steve.

Good afternoon, all.

I'm pleased to join you today to present a summary of our full year 2024 financial results.

Starting with operating expenses, For the year ended December 31, 2024, revenue totaled $1,000,000 in connection with an upfront license fee related to the exclusive license and collaboration agreement with Kuva Labs, Inc.

The company did not have any revenue for the year ended 12/31/2023. For the year ended 12/31/2024, operating expenses totaled $23,400,000 compared to $25,700,000 for the year ended December 31, 2023. Representing a decrease of $2,300,000 or 8.9%.

Research and development expenses were approximately $11,300,000 for the year ended 12/31/2024 compared to $12,700,000 for the year ended December 31, 2023. Representing a decrease of approximately $1,400,000 or 11%.

This was primarily due to a reduction in expenses associated with the Phase 2b ASCEND trial which completed enrollment in the prior year lower spend on chemistry, manufacturing and controls, and lower equity expense.

General and administrative expenses were approximately $12,100,000 for the year ended 12/31/2024, compared to $13,000,000 for the year ended 12/31/2023. Representing a decrease of approximately Was primarily due to one off related severance costs in the prior year associated with the elimination of the Chief Business Officer position, on May 1, 2023, a reduction in equity expense, a decrease in directors and office officers' insurance premiums and a reduction in spend on legal fees, partially offset by one off settlement related costs and an increase in consulting expenses. Overall, net losses were $20,000,000 and $20,800,000 for the years ended December 31, 2024 and 2023 respectively. 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 December 31, 2024, we had cash, cash equivalents and marketable securities of approximately $31,200,000 Based on Wassada's existing and planned activities, the company believes available funds will support current operations into the second quarter of twenty twenty six. Lastly, an update regarding the net operating loss sale. Earlier this year, we received 900,000.0 in non dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority.

The program enables qualifying New Jersey based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations with a lifetime cap on the tax benefit sales of $20,000,000 To date, under the program, we have sold $19,600,000 in tax benefits for net proceeds of $18,400,000 With that, I will now turn the call over to Doctor. To provide an overview of the company's development programs. Kristen?

Thank you, James, and good afternoon, everyone. Before I review our development portfolio, allow me to summarize some especially for those who are listening to me for the first time. Despite advances in cancer therapy, many solid tumors are still associated with poor outcomes. Advanced solid tumors such as pancreatic cancer, gastric cancer and glioblastoma multiform are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor. In addition, many solid tumors also harbor a hostile tumor microenvironment which suppresses a patient's immune system and makes it less effective in fighting cancer cells. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This coupled with the fact that most anti cancer therapies are not efficient in targeting only cancerous tissue defines the major challenges in treating solid tumors. To overcome these obstacles, our investigational products or Tepatide, a leverages the naturally occurring SendR active transport system to selectively deliver anticancer drugs through the tumor stroma and into the tumor. Simultaneously, the tumor microenvironment making it less immunosuppressive and therefore, increasing the tumor susceptibility to immunotherapy and our body's own immune system while also inhibiting the metastatic cascade For more specifics regarding certepatide's mechanism of action, I invite you to visit our website and view the animated video pertaining thereto as well as the relevant slides in the corporate presentation.

Beyond our strategic clinical development plan, we have focused on optimizing our regulatory strategy. To date, our approach has yielded significant results for stratepatide, with special regulatory designations across multiple health authorities, These include several orphan drug designations a fast track designation and a rare pediatric disease designation. One such achievement occurred this past September when certepatide was granted an orphan drug designation by The U. S. For the treatment of cholangiocarcinoma. As mentioned, our regulatory and clinical development strategy for prioritizes rapid registration We are actively evaluating certepatide's potential as a selective tumor targeting and penetrating enhancer and tumor microenvironment modifier in combination with a variety of standard of care therapies in advanced solid tumors. Now for an update on our individual development programs. The ASCEND trial. A one hundred and fifty eight patient double blind randomized placebo controlled clinical trial evaluating cerptepatide in combination with standard of care gemcitabine and nab paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. The trial is being conducted at 25 sites in Australia and New Zealand led by the Australian Gastrointestinal Cancer 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 LASADA inherited upon our acquisition of SEND Therapeutics.

The original trial was designed with more of an academic nature, rather than one with commercial objectives and was statistically powered based on a six month progression free survival primary endpoint. After the acquisition, LASADA collaborated with the sponsor of the trial AGITG, to modify the trial to ensure it provided clinical outcomes that would best support the next steps in development of Sertepatide from a regulatory perspective. As such, the ASCEND protocol was amended to include an additional cohort of patients, cohort B, not statistically powered to evaluate an additional certepatide 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 the gold standard endpoint in pancreatic cancer trials. Since the SN protocol was amended, following trial initiation, data from Cohort B is lagging Cohort A data by several months. Cohort A with ninety five patients receiving a single IV dose of certepatide or placebo, in combination with standard of care completed enrollment in the third quarter of twenty twenty three. As recently announced, preliminary cohort A 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.

Data from Cohort B with sixty three patients receiving two IV doses of certepatide placebo administered four hours apart, in combination with standard of care are expected in the coming months with a final analysis of both cohorts available thereafter. The Bolt trial is our Phase 2a double blind placebo controlled multicenter randomized trial in United States evaluating certepatide 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-twenty twenty five. A second cohort has been added to the BLSTR trial evaluating certepatide in subjects in second line cholangiocarcinoma on top of standard of care. With more than thirty percent of the patients enrolled in the second line cholangiocarcinoma carcinoma cohort we continue to target later this year for the completion of enrollment. [indiscernible] [indiscernible] is a Phase IbIIa open label trial in The United States evaluating Serteplatide in combination with neoadjuvant Fulfiranox based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the company announced enrollment and completion in all three cohorts This single center study being conducted at the University of which period to ensure patients met specific criteria before receiving treatment with certepatide.

Of the sixty six patients enrolled, fifty met these criteria and were treated with certeplatide 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 The trial will provide LASADA with valuable pre and post treatment tumor tissue data for immuno profiling, Along with long term patient outcome information, We anticipate data in the coming months and we will share the key findings when available. Sheelu Pharmaceutical the licensee of Certepatide in the Greater China territory is also currently evaluating Certepatide in combination with gemcitabine and nab paclitaxel, As a treatment for metastatic pancreatic ductal adenocarcinoma, Chhelo is currently treating patients in their Phase two placebo controlled trial in pancreatic cancer. They recently reported that they completed enrollment with the revised target enrollment of ninety six patients. The revised study is still sufficiently powered and this change will expedite the study and allow for early earlier data analysis in preparation for a Phase three trial. According to guidance from Qilu, data are expected in the next twelve to eighteen months with a Phase three study planned to start thereafter. In collaboration with AstraZeneca and and the funding sponsor of the Lisata trial, WARP9, we are evaluating certepatide in a Phase IbIIa randomized placebo controlled three arm single blind, single center, safety, early efficacy and pharmacodynamic trial.

The trial is being conducted in Australia evaluating certepatide in combination with the checkpoint inhibitor durvalumab plus standard of care gemcitabine and nab paclitaxel chemotherapy versus certepatide in combination with standard of care know dervalumab versus standard of care alone. In patients with locally advanced nonresectable pancreatic cancer, Preliminary results from the first seventeen of thirty patients enrolled in the Lisata trial were presented at the twenty twenty five ASCO GI Symposium. The interim analysis suggests that Sertepatide in combination with standard of care chemotherapy and immunotherapy improves treatment outcomes for patients with locally advanced nonresectable pancreatic cancer while also provoking tumor infiltrating lymphocytes in subjects who have recist responses. These findings also support pre clinical data indicating that certepatide enhances the effectiveness of immunotherapy. With twenty seven of the thirty targeted patients enrolled, enrollment remains on track to be completed by the first half of twenty twenty five. A study of certepatide in combination with temozolomide in glioblastoma multiform or brain cancer 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 certepatide when added to standard of care temozolomide versus temozolomide alone and matching certepatide placebo in subjects with newly diagnosed glioblastoma, 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 two:one certepatide plus standard of care versus placebo plus standard of care. Enrollment completion is targeted for the second half of twenty twenty five. Fortified is currently planned to be a Phase 1b2a double blind placebo controlled, three arm randomized study in The United States evaluating the safety, tolerability, and efficacy of a four hour continuous infusion of certepatide in combination with standard of care in patients with first line metastatic pancreatic cancer who have progressed on Fulphurinox excuse me, second line metastatic pancreatic cancer who have progressed on Fulfuronox. As part of this study, we have engaged Haystack Oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study, as an exploratory endpoint for analyzing the early therapeutic effect of certepatide, Las Vegas is currently evaluating alternative strategies to achieve the fortified study objective with a focus on identifying options that are faster, and or less expensive, We hope to have more to share in the coming months. Additionally, Lasata recently entered into several preclinical research collaborations to further investigate the therapeutic potential of [indiscernible] These collaborations encompass both oncology and other therapeutic areas and are intended to identify new strategic opportunities for the drug's development.

These collaborations include a sponsored research agreement with the University of Cincinnati to assess their tirptepatide in combination with bevacizumab a VEGF inhibitor in a preclinical murine model the treatment of endometriosis. This trial is the first exploration of certepatide in a non cancer related indication and aims to assess if Certepatide can improve the delivery of bevastatin which potentially reducing lesion burden in abdominal pain Data from this preclinical trial are currently under review And while early signals are encouraging and suggest the potential for further investigation, The company will need to evaluate the financial resources required to determine the best path forward. A partnership with Velo Therapeutics to investigate the benefits of combining certepatide with Velo's Pepticrad a customizable oncolytic adenovirus platform technology and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.

And as previously noted, following results from an earlier preclinical study, LOSADA entered into a global license agreement with Kuva Labs to explore the synergistic potential of Certepatide 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 twenty twenty six. Relatedly, Lasota will provision certain certepatide TAKUVA for its clinical study via clinical supply agreement. This collaboration reinforces our belief in the broad applicability of certepatide beyond a therapeutic setting. Beyond the clinical studies I've outlined, we are actively exploring additional opportunities to advance our development strategy, including progressing certepatide in combination with gemcitabine and nad paclitaxel into a Phase three study in 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 studies I mentioned earlier, I investigated and investigator initiated trials although we have great confidence in the investigators running these studies, LOSADA has limited control and thus timelines, and expectations may be subject to change.

That said, we are extremely grateful to the investigators and especially to the patients participating in certepatide clinical trials around the world. For those who are interested, a more comprehensive description of each trial is available on the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two slides that depict the anticipated timing and execution of key milestones and data readouts from our trial. As Doctor. Mazzo previously mentioned, 2025 will be a data rich year for LASADA Lisata we are looking forward to reporting those results. With that, I will now turn the call back to Dave. Thanks, Kristen. Overall, we achieved our target milestones in 2024. Positioning us well for continued success in 2025.

We look forward to sharing further corporate and development updates throughout throughout the year, including key information regarding our ongoing and planned trials as they become available. We believe that certepatide represents a significant opportunity to create both meaningful patient benefit and long term shareholder value. With that overview operator, we're now ready to take questions.

Our first question comes from Sarah Nik with H. C. Wainwright. You may proceed. Hi. This is Sarah on for Joe Pantginis.

I had a question regarding the ASCEND trial. I know you can't exactly speak to timing but regarding the data cut that's expected from Cohort B, Can you give any insight into what kind of data we could expect? Would it be along the similar lines of what we saw earlier this year from Cohort A? Thanks.

Hi, Sarah. Thanks very much for the question and giving me the opportunity to clarify. For the Cohort B data, we expect something that would be akin to what was reported for Cohort A. That is an analysis of both progression free survival and at least the preliminary, if not final overall survival of all patients in that cohort. So we're looking forward to that because those data will be indicative of final trial results and also will give us a good head start into planning for Phase three assuming that they'll be supportive.

Okay, thanks. That's helpful. Thank you.

Thank you. Our next question comes from Pete Enderlin with M and A Partners.

You may proceed. [indiscernible] So just following up on that with regard to ASCEND Cohort B, you said coming months, you be a little more specific? Is that you hope by the end of the year or in the third quarter, fourth quarter? What does that look like? So the best I can do, Pete, because as I think we've explained at least in writing in in the past that I can take a moment here to repeat it We are under contract with AGITG and the CTC of the university of Sydney do not have any control over the release of the Lisata.

This is an investigator initiated set of trials and so they control the data release. As best as we know right now, the plans are to attempt to have all of the analyses done in time to submit an abstract so that the data could be presented at the American Society of Clinical Oncology or ASCO meeting which is the last May, June, this year. If they get their analyses done on time and submit that abstract, then that would be the Lisata of the public disclosure most likely. If they missed the deadline for the submission of the abstract, the next relevant major international scientific meeting is ESMO, the European Society of Medical Oncology and And that would be in I think actually October So to narrow it down, it's most likely going to be sometime from second through third quarter of this year that the data will become available. Although we're working with them them being the AGITG and CTC, to see if they can get the analyses done faster and allow for release of the information under other circumstances. So that's the best we can say right now. Well, thanks. That's great. I actually expected you to say ask in January of next year.

So that sounds very encouraging. Now I have asked a question that's a little bit abrupt or brisk or whatever you want to call it. And that is when you reported the cohorts A results preliminary data about a month ago, the stock had a severe reaction I think it's fair to say. And so the question is, miss or misinterpret [indiscernible] What is really the import, but what is street misunderstand or not quite realize when you report those results. Well, thanks also for the opportunity to speak to that. Remember, I am I can't speak for The Street, if you will, or for any particular shareholder So we'll just give our interpretation of what happened. There was a run up in value leading up to the date of the asset announcement. And I think there was level of anticipation of what the data would would be I expect that [indiscernible] the the type of retail investors that we have and the size of many of their holdings, which are relatively small, that there was a euphoria, if I can say, expecting that we could have made an announcement that would be earth shattering or breakthrough. And when the data weren't by their judgment, earth shattering or breakthrough then they were disappointed.

As we've said in our press release, The reason we added Cohort B was because we anticipated the type of results that we got out of Cohort A, which is results that trend in the right direction are actually consistent with what we've seen in every other trial pre clinically and clinically but perhaps not fully refined and that's because we were working on optimizing the dosing scheme and that's why we added Cohort B in the first place. And so for us, it wasn't a big surprise. But I think for certain people who perhaps didn't understand the nuances of the trial design, or simply were betting on a big announcement that's why they were disappointed. It's unfortunate because it's the full trial that counts not any bits and pieces. Yes, thanks. That makes a lot of sense. Can I just ask one more quick one? Sure. Go ahead. And that is, will the Kuva deal [indiscernible] let's say, future diagnostics that will enable [indiscernible] analysis in clinical trials, say, in Phase three clinical trial that would look at tumor sizes and all that sort of stuff or is it not really directly related to that?

Well, once again, I will give you my interpretation and conclusions based on the transaction with Kuva and discussions with their head but I can't speak for Kuva. So I want to make that very, very clear. Kuva speaks for themselves. But I believe that the intention with Cuba is to do exactly what you just described, not only for clinical trials, but actually as a personalized medicine for treatment of actual patients once Sertepatide is approved. So the goal is to [indiscernible] Identify those patients and those tumors that are particularly susceptible to increased permeability in the presence of certepatide, and therefore demonstrate though or identify those patients who would [indiscernible] [indiscernible] with circapatide in their anti cancer treatment regime. So I think that's exactly what they intend to do. And I think we'll be doing it collectively, both clinically and hopefully eventually commercially. Great. Thanks, Dave. You're welcome. Be well, Pete.

Thank you. Our next question comes from Steve Brozak with WBB Securities. You may proceed. Hey, guys. Thanks for taking the questions. I do have a question and it's not about timing or outcomes per se and in terms of when the data comes out. But what are some of the expectations not from yourselves, but what you've been talking to a number of pharmaceutical partners. What are they looking for in data that would have appealed to them? Obviously, pancreatic cancer is a is a critical disease and it's always found late and you obviously are looking at improving outcomes clinically in a significant fashion. What can you tell us in any granularity without talking about timing that you would be looking that pharmaceutical partners have told you that they're looking for and I will hop back in the queue. Thank you.

Hey, Steve. Thanks very much for joining and for the question. So in general, what I'll say is not particularly profound because it would apply almost to any oncology program at which a large pharma company would be looking and considering. But in our [indiscernible] the complete trial results from the ASCEND trial for the reasons I just explained to to the prior caller, the complete trials would count. And also a consistency of both therapeutic effect and safety. And so they want to know that the drug works consistently that we have a good handle on the relative magnitude of that effect so that we can appropriately size and power and optimized Phase three registration protocol and that there have been no untoward safety signals that have come out of exposure to larger populations. And so up until well, let's just say to date, we've been able to to do that. And we'll be expecting to be able to do that hopefully with the results from Cohort B when we get them. Of course, this is all done in the context of in comparison with standard of care. Right? The whole point of the matter is that the addition of certepatide is designed to improve standard of care.

So I'm talking about therapeutic effect. I'm talking about the combination of the cytotoxic gemcitabine and naphtha'scotoxal with [indiscernible] and seeing that they have an improved effect over [indiscernible] I for as a legal term, For the purposes of clarity, when you're talking about improvement effect and obviously it isn't a lapping matter, We're talking about people who are predictably unfortunately going to to die. And you are looking at being able to improve those outcomes. Is that without getting too granular, is that a fair statement?

That is exactly the case. Yes, sir.

Okay. Let me hop back in the queue. Thanks for taking the questions. Thank you. You're welcome. Next question comes from Kent D'Olive with Brookline Capital Markets. You may proceed.

Great. Thank you. Most everything is pretty straightforward here, but you have an interesting comment about the FORTITFID trial and alternative approaches to achieving the study objective Are you in a position to elaborate on any of that? Ken, thanks for joining and appreciate your question. Thank you. I can say what we're thinking. Originally, the the FORTITI trial was designed to Lisata further information around the pharmacokinetics of [indiscernible] And the original concept was that it would have to have its conclusions based upon both overall survival data in patients And as we know, they take a long time to get to, And it's sort of a perverse situation, but the better the drug works, the longer it takes to get that information. And so we've been considering other ways and now that we have a strategic partnership with Kuva, it prompted the thought process around a possible means of eliciting the same information [indiscernible] imaging techniques and imaging endpoints for these purposes. Now we haven't yet refined that and we're certainly not in a position to discuss a protocol, but that's what we're talking about. So if it if the idea works, should be able to derive the type of information that we were looking to get from Fortified in both a fraction of the time and at a fraction of the cost.

And obviously, that's very appealing.

That's great. Thank you.

Thank you, Kim.

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

Well, again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support Stay well.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.