Lisata Therapeutics, Inc.

Welcome to the Losada Therapeutics First Quarter 2023 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. To ask a question at that time, please press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded today, Tuesday, May 9, 2023. I'll now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Losada. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to Losada's first quarter 2023 conference call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Dr. David Mazzo, Chief Executive Officer, Dr. Kristen Buck, Executive Vice President of Research and Development, and Chief Medical Officer, and James Nisko, Vice President of Finance and Treasury. Shortly before this call, we issued a press release announcing our first quarter 2023 financial results, which is available under the Investors and News section of the company website, along with the webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's email distribution list, please email me at jmendito at lazada.com. Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements and involve risks and uncertainties regarding the operations and future results of this data. 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 statement. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, May 9, 2023. Lizada 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?

Dave, I believe you may be on mute. There we are.

We're having technical difficulties today. My apologies, everyone. Thank you, John, for the introduction, and good afternoon, everyone. And thank you once again for joining us as we provide an overview of recent business highlights, discuss our first quarter 2023 financial results, and give an update on progress of our various development programs. During the first quarter, the vast majority of our efforts remain focused on advancement of our clinical development programs for the treatment of advanced solid tumors. As those who follow us now know, Lasada is a clinical stage therapeutics development company with a novel solid tumor targeting and penetration technology to improve the efficacy of anti-cancer drugs. Our development portfolio contains programs that are designed to bring significant therapeutic improvement in the treatment of solid tumors in a pharmaco-economically attractive paradigm. Lista 1, our lead product candidate, is the subject of multiple planned and ongoing clinical trials being conducted globally in a variety of solid tumor types and in combination with multiple anti-cancer agents of differing modalities. Based on substantial preclinical and, most importantly, early human clinical data, we believe that LISTA-1 has the potential to become an integral part of a revised standard of care treatment regimen for many difficult-to-treat cancers. Our chief medical officer, Dr. Kristen Buck, shortly will provide more specifics on our clinical programs following our review of financial results. However, before we get to those subjects, I will take a moment to elaborate on the organizational change that we announced last week. Operating a sustainable clinical stage biopharmaceutical business involves constant vigilance of capital utilization and often difficult decisions by management teams and boards of directors involving programs and people. The need for scrutiny of resource allocation has become even more acute in the volatile and unpredictable capital markets environment of today and that may exist for the foreseeable future. With that in mind, and coupled with our operational imperative to ensure that we have sufficient capital to reach important data milestones for all our clinical development programs, we recently implemented a number of capital-preserving measures based on an updated review of business priorities and capital allotment. Among the measures that were enacted was the streamlining of our organization at the non-executive and executive level. As part of this organization optimization, the position of president and chief business officer was eliminated, and David Slack's employment with the company was ended. On a personal level, we are saddened to see David's departure from Lasada, and I will take this opportunity to publicly acknowledge his many contributions to the evolution of SEM Therapeutics and the transaction that formed Lasada. David was instrumental in leading the efforts to identify a means by which to exploit the promise of ListaOne in a comprehensive clinical development program, as he was in the licensing deal of ListaOne with our Chinese partner, Qilu Pharmaceutical. We are grateful for his past contributions and wish him well in the future. And with that, I now will turn the call over to James Nisko, our VP of Finance and Treasury, to review and provide commentary on our financial results. James?

Thanks, Steve. Good afternoon, all. I'm pleased to join you today to present a summary of our first quarter 2023 financial results, starting with operating expenses. Research and development expenses were approximately $3.2 million for the three months ended March 31st, 2023, compared to $3.3 million for the three months ended March 31st, 2022, representing a decrease of 0.1 million or 3.2%. This was primarily due to expenses associated with our Exona Phase IIb study, the FREEDOM trial, in the prior year, partially offset by study startup activities in the current year associated with the planned Phase II proof-of-concept bolster trial studying Lista 1 and various solid tumors in combination with the corresponding standards of care. enrollment activities for the LISTA I Phase IIb Ascent Study, and chemistry and manufacturing and control activities for LISTA I. General and administrative expenses were approximately $3.7 million for the three months ended March 31st, 2023, compared to $3.3 million for the three months ended March 31st, 2022, representing an increase of $0.3 million, or 9.8%. This was primarily due to the addition of one employee acquired through the merger with SEND Therapeutics, an increase in external legal fees, and an increase in accounting and tax-related fees. Overall, net losses were $6.2 million to the three months ended March 31, 2023, compared to $4.2 million for the three months ended March 31, 2022. Turning now to our balance sheet and cash flow. As of March 31, 2023, the company had cash, cash equivalents, and marketable securities of approximately $61.1 million. These figures do not include the recently announced $2.2 million in non-diluted funding that we received as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority, which will be recorded in the second quarter of 2023. As we have reported previously, the program enables qualifying New Jersey-based biotechnology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations. With several operational initiatives underway that will help manage external costs and, as Dave mentioned, the elimination of the president and chief business officer position, we now project that our current available capital should take us into the first quarter of 2026, encompassing anticipated data milestones from all of our ongoing and planned clinical studies. This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for the review of our clinical development pipeline. Kristen?

Thank you, James, and good afternoon, everyone. I realize that we just reviewed our programs a few weeks ago during our full year 2022 results call, but I believe it's important to keep our stakeholders up to date on the continuous progress being made by the Lissata team. Lissata's pipeline is built on a portfolio of proprietary and patented technology that is grounded in strong scientific rationale and a body of published preclinical and early clinical data. Our technologies are designed to address major impediments to successful treatment of solid tumors in the context of increasing pharmacoeconomic pressures on the healthcare system. We appreciate the critical importance of generating meaningful clinical data to advance our platform technology, and I can assure you that our entire organization has this goal top of mind in everything we do. With that, I will now provide a summary and status update for each of La Sata's active clinical development programs, kicking off with our lead product candidate, LSTA, or LISTA-1. for the treatment of advanced solid tumors in combination with other anti-cancer agents. Despite advances in cancer therapy today, many solid tumors remain difficult to treat effectively. Cancers such as pancreatic cancer, gastric cancer, and other solid tumors are surrounded by dense fibrotic tissue known as stroma, which limits access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile TME negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers. This, coupled with the fact that most anti-cancer therapies are not efficient in targeting only cancer tissue defines the major challenge in maximizing effectiveness and safety in the treatment of solid tumors. To combat this, Lasada's approach is to activate the C-END rule or SEND-R system, a naturally occurring active transport system to selectively deliver anti-cancer drugs through the stroma and into the tumor. Lysada's lead product candidate, Lista-1, is an investigational drug that actuates the SendR active transport mechanism while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. Lista-1 targets tumor, vascular, endothelial cells, as well as tumor cells themselves, based on its affinity for alpha-V, beta-3 and beta-5 integrins that are upregulated on these cells, but not necessarily healthy tissue. Lista-1 is a 9-amino acid cyclic internalizing RGD peptide that, once bound to these integrins, is cleaved by proteases expressed in the tumor microenvironment to release a peptide fragment called the SEND-R fragment. The Sendar fragment then has high affinity for and binds to an adjacent receptor called Neuropilin 1, also upregulated on tumor vascular endothelial and tumor cells, to activate the CN rule active transport pathway and ferry anti-cancer drugs more efficiently into solid tumors. Additionally, Lista 1 has been shown in a range of preclinical models, to modify the tumor microenvironment, making it less hostile to immune cells and adding to the efficacy of anti-cancer drugs used against solid tumors. These results come internally from Lissata and from collaborators and research groups around the world and have been the subject of over 200 scientific publications. Along with our collaborators, we have amassed significant clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA-based therapeutics. Clinically, LISTA-1 has demonstrated favorable safety, tolerability, and activity to enhance delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LISTA-1 to enhance a variety of anticancer treatment modalities in a range of solid tumors. Currently, LISTA-1 is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors. Let me touch on a few of these individually. Firstly, the ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled clinical trial evaluating Lista-1 in combination with gemcitabine and nabpaclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The trial is being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group, or AGITG in collaboration with the NHMRC Clinical Trial Center at the University of Sydney. We are very pleased with the work of AGITG. To date, and enrollment is progressing quite well. We originally projected enrollment completion by the second quarter of 2024, but if current enrollment rates continue, we could complete enrollment sooner than that. Just recently, along with our clinical research partner, WARP9, we treated two of our first patients in the I-Lista trial in Australia, evaluating Lista1 in combination with standard of care gemcitabine and nabpaclitaxel chemotherapy and immunotherapy, that is, durvalumab, as a first-line treatment in locally advanced, non-resectable pancreatic ductal adenocarcinoma. This is the first of several planned trials in which we are expanding the study of LISTA-1's impact on existing therapies to include immunotherapies. We also expect enrollment completion in this trial by the second quarter of 2024. Next is CENDIFOX. CENDIFOX, the Phase 1b-2a open-label trial of LISTA-1 in combination with neoadjuvant fulfirinox-based therapies, in pancreatic, colon, and appendiceal cancers continues to make steady progress, and we expect enrollment completion by the fourth quarter of this year with data readouts in 2024. This trial will provide us with post-treatment biopsy immunoprofiling data as well as long-term outcome data. LISTA-1 is also currently being evaluated in combination with gemcitabine and nabpaclitaxel in a Phase 1b two-way open-label trial in China, led by our licensee in that territory, Qilu Pharmaceutical. Preliminary progression-free survival data are expected to be presented at the upcoming ASCO meeting in June. The company's bolster trial of LISTA-1 is a Phase II placebo-controlled basket trial evaluating LISTA-1 in combination with standards of care in advanced solid tumors, including head and neck, esophageal, and cholangiocarcinoma. This trial will include both cytotoxic and immunotherapy standards of care. We're excited to announce this trial is now up and running, and we hope to announce enrollment of the first patient by the end of the second quarter. Lastly, iGO-Lista, a Phase 1b-2a proof-of-concept safety and early efficacy study evaluating Lista-1 in combination with Nivolumab and Fulfironox as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma is on track to initiate by the third quarter of this year. In addition to the clinical trials I just mentioned, we also plan to have other studies up and running in the next few months, including Lista-1 in combination with temozolomide in glioblastoma multiforme, or GBM, as well as Lista-1 in combination with HIPEC interoperative intraperitoneal lavage in patients with peritoneal carcinomatosis. For those who are interested, a more complete description of each of our trials is available in the appendix of the corporate presentation available on our website. Additionally, in the body of the presentation, there are two slides that depict the anticipated timing of all data readouts from our trials. Turning now to Lista 12, also known as Hanedra in Japan, our product candidate for the treatment of critical limb ischemia, or CLI, and Berger's disease. Honedra is the company's Sakagaki-designated product candidate for the treatment of CLI and Berger's disease in Japan. As we have reported for several quarters, we have completed a registration-eligible study of Honedra in Japan, and those data from that study form the basis of a pre-consultation and, ultimately, a consultation process with the Japanese regulatory authorities to determine the next step of development for the program. To date, the PMDA has provided advice on how to prepare for the formal consultation meeting and has indicated their preference for additional clinical information to accompany the filing of a JNDA. As a result, we are considering our options for next steps and have engaged a specialized boutique firm to assist in our efforts to secure a Japanese partner to complete the remaining steps of development and registration as well as eventual commercialization in Japan. Lastly, LSTA-201 for the treatment of diabetic kidney disease, or DKD. In 2022, the company initiated a Phase 1B open-label proof-of-concept trial evaluating Lista-201, a CD34-positive regenerative cell therapy investigational product for intrarenal artery administration. in patients with diabetic kidney disease. Our proof of concept protocol had the objective of determining the tolerance of intrarenal cell therapy injection in DKD patients, as well as the ability of Lista 201 to regenerate kidney function. As we reported on 6 February 2023, the top line results from the study showed that Lista 201 was safe and well tolerated by patients. with no serious adverse events related to the therapy. However, the study did not demonstrate a consistent improvement in kidney function among all patients. That said, encouragement received from the study's principal investigator and key opinion leaders led us to conclude that there still may be potential for use of CD34-positive cell therapy for the treatment of diabetic kidney disease. Further development of LISTA 201, though, will certainly require significantly larger studies in capital investment, and thus, development by LISATA would only be continued if a strategic partner that can contribute the necessary capital for future development is identified. With that, I will now turn the call back to Dave.

Thanks, Kristen. As Kristen has outlined, the Lasada team is making continual progress advancing our development programs with the goal of maximizing the potential of our development pipeline. We have designed our studies to be scientifically and medically rigorous and to provide results expeditiously while also assuring that we are operating in a maximally capital-efficient manner. We are excited by the promise of our platform technology and are committed to achieving meaningful data readouts as soon as possible with the goal of benefiting patients the physicians who treat them, and our shareholders. And with that, operator, we're now ready to take questions.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions. Our first question comes from Steve Brozak with WBB Securities. Your line is open.

Yes, hi. Thanks for taking the question. In listening to the list of trial approaches, I'm seeing that everything is really adding to the current standard of care in all of these critical indications. What kind of feedback are you getting from your clinician partners that you're working with on what they're seeing, the importance, and how this basically works into what they've done in the past. And I'll hop back into the queue after that. Thank you.

Thanks, Steve. Nice to talk to you and appreciate your question. So, you know, before we started these trials, Kristen spent a good deal of time talking to key opinion leaders, you know, influential practicing oncologists throughout the country and, in fact, throughout the world. to get their feedback on where the highest unmet medical needs were, which solid tumors were the ones where we could make a biggest difference, and whether or not they felt that the approach that we were espousing actually was sensible to them. And the feedback that we got then, which led to the initiation of these trials, and the feedback that we continue to get is that the clinicians are extremely enthusiastic about the prospect of taking existing standards of care and actually making them optimized, making them work maximally in terms of efficacy without causing any further detrimental safety issues. They think that this is an approach that will be faster to conclusion, faster eventually to potential market, and faster to patients in the long run than brand new NCEs that have to start developing an efficacy profile from scratch. And they also believe that In this pharmaco-economically challenging environment where the Inflation Reduction Act and other pressures are putting increased scrutiny into drug prices and looking for ways to introduce innovation in a cost-effective manner, the ability to take something as simple as a small cyclic peptide and use it to significantly augment the efficacy of known drugs, many of which are already generic or will be generic, seems to make a lot of sense to them. And of course, our trials are mostly blinded, so they can't see any specific results per se, but there's a strong sentiment among them that LISTA-1 is doing exactly what we purport it to do.

Can I tack on one addendum? On the regulatory side, given the fact that you obviously, it's one of the considerable hurdles in these spaces, What do you see there in terms of the advantage? And again, this time I will hop back into the queue.

Well, I think the advantage from a regulatory perspective is to some extent obvious. When you're just adding something into an already existing regimen, and by adding I mean we simply co-administer these products. So there's no, you know, the only mixing, if you will, that takes place is inside the body. That makes formulation and stability and all of those chemistry and manufacturing control issues simpler to deal with. These are not new chemical entities in the sense that we're not tethering the anti-cancer agents with Lista-1. So lots of preclinical work doesn't need to be done. Separate toxicology doesn't need to be done of these new entities. And the fact that Lista-1 in and of itself seems to be so benign from a safety perspective is makes this very easy to go you know to predict and so we've had very positive interactions with the fda the tga in australia and we've just started our interactions with the the ema in europe and so far we haven't seen any particular hurdles and the discussions are proceeding as we expected got it again thanks for taking the questions and let me hop back into queue thanks steve

Thank you. Our next question comes from Kemp Dolliver with Brookline Capital Markets. Your line is open.

Great. Thank you. A couple of questions regarding the ASCEND trial. First is you amended the trial protocol in the last few months, and I want to get more details regarding the changes and the rationale for the changes.

Certainly, Tim. Thanks for dropping on the call and for the question. So we actually will be releasing some information in the next couple of weeks. We will give a much broader discussion of the evolution of ASCEND, but I can give a top-line summary right now. When ASCEND was started, it had sort of a single purpose, was to replicate the Phase 1b, 2a data, but in a placebo-controlled trial. And the AGITG did something that typically a commercial drug developer wouldn't do, but they actually decided that they wanted to power the trial to determine some efficacy endpoints as well. So that was the trial that we inherited. When we looked at that trial, we thought that that was great, but there were at least one other thing that we thought should have been done And that's the basic tenet of the amendment in that we added a second cohort of patients, you know, very creatively called cohort B. And that second cohort actually will receive two doses of Lista-1 separated by about four hours. So they still receive gemcitabine, napactetaxel, and Lista-1 essentially co-administered at the start. But four hours later, they'll get a second dose of Lista-1. And the reason for that is if you look at the pharmacokinetic profiles, the C-max, the T-max, and the half-life of these different compounds, you realize that gemcitabine has a half-life of roughly two hours or 90 minutes or something like that. Lista-1 has a half-life of about the same. But napaclitaxel has a half-life of about 10 to 12 hours. And so there was at least some thought process that said if you waited, you know, two or more half-lives after the first dose of Lista-1, essentially you're outside the therapeutic range of Lista-1. Gemcitabine is all gone, but you're still within the therapeutic range of napaclitaxel. And a second dose of Lista-1 might provoke improved penetration of the remaining napaclitaxel into the tumor and might have a positive effect on tumor efficacy. So in some ways, this is part of what would be a typical Phase IIb trial in that we're doing a little bit of dose ranging, if you will, as part of the trial as well. But we have now also these two cohorts, and so we can compare each cohort against placebo, and then the two cohorts against each other, and then perhaps the combination of the two cohorts, if there's no difference, against placebo as well. and get a really strong indication of therapeutic effect size as well as safety profile for the, what would be likely the phase three trial that would follow.

Great, that's helpful. So, you know, you mentioned powering and I think registrational trial, but that would seem to be, say, is it fair to say that that's possible but low probability?

Yes, that's our expectation. is not that this will be a registration trial, but that it will be a solid support for designing a registration trial that will go forward. Now, that said, we will pursue every avenue with FDA and especially the TGA in Australia, where the majority of the sites are for this trial, to see if the data are positive and statistically significant, if they would consider an accelerated path or a conditional path to approval.

Super. Thank you.

Thanks, Kim.

Thank you. Our next question comes from Pete Enderlin with Moz Partners. Your line is open.

Thank you. Hi, everybody. Thank you. Conceptually, I thought that originally the idea was that LISTA-1 could either be co-administered, which is what you were just talking about, or tethered. And you just said, David, that that's not really what you're anticipating now. So is it true that you're really not contemplating? Let me clarify. Okay.

Okay. So, so the, the, the two approaches, either co-administration or tethering remain distinct possibilities. I think, you know, in the past I've described the co-administration approach as the rapid most rapid approach to a first registration for the reasons that I outlined briefly a moment ago with with tethering you create a new chemical entity that needs to be fully characterized and you know both biologically and chemically and those are much you know you're basically starting from zero with that kind of a product with with Co administration you're basically starting using the knowledge base of the established standard of care and just adding on to it. So it's a simpler, faster, most likely less expensive way to getting to answers and to a registration. And that's what we're pursuing first. But it doesn't mean that tethering is off the table. It just means it's second in line from a priority perspective internally.

Thanks for clarifying that. And then sort of looking several years ahead, but but that's what we try to do. When you're talking about combination therapies, which is what these all are, and the agreements that you have are the ones that you contemplate and try to enter into, do you tie the sales and the pricing together or is each company sort of on its own and they're separate and independent for each entity that you bring to the party in a particular application or indication? For example, I mean, You can have gemcitamine or paclitaxel and Lista-1, and you could either have a package sale or sell them and price them independently. So which way do you typically anticipate going?

So right now the anticipation is that this will be an add-on to existing therapy. And as I said, those therapies could already be generic or could become generic by the time we get to market. But our product will not be generic. It will still be under patent, and it will be priced accordingly as an add-on, which augments efficacy of those less expensive and more tried and true, well-characterized standards of care. So I think that it would be unlikely, based upon our current thinking, that we would bundle these, meaning actually package them together and price them as a bundle because we wouldn't own the other products. We wouldn't be in position to manufacture them. We could source them and bundle them, but there's no real benefit necessarily to doing that. And what we're doing is looking to create, you know, a large list of non exclusive opportunities that essentially demonstrates that in combination with certain products, those products get better. and so their sales will benefit, and it only works if they add on with us, and so we will benefit separately. Now, as we get further along, it's not completely out of the question that someone would want to make this an exclusive benefit in a class of compounds, and so we would price a deal for exclusivity appropriately in that case.

So, but in the initial agreements that you have with these other players. You don't really spell out exactly what any such combination.

The current agreements are essentially development agreements. They just say that we will work together to demonstrate, hopefully, that the addition of LISTA-1 improves the products that are already considered standard of care. And if that works, as I said, you know, that will be enough to improve everyone's bottom line in the long run. But, you know, at that point, it's possible that those companies may want to enter into exclusive deals to prevent us from being combined with other compounds of the same class in those indications. And in order to get exclusivity like that, the deals would have to be much richer as it relates to us.

Right. Okay, great. Thanks a lot.

Sure. Thanks, Pete.

Thank you. Our next question comes from Joe Pantgenis with HC Wainwright. Your line is open.

Hey, everybody. Good afternoon. Thanks for taking the question. Two questions, if you don't mind, Dave. So first, you know, it's nice to see you guys continuing with your track record on cash management, especially in the continuing environment. So with that said, I guess my two questions really are, Obviously, you're expanding your clinical trial, so that will be the lead driver for expenses increasing, but where do you currently stand on your current manufacturing needs for LISTA-1 as well as your interim to more long-term needs?

Thanks, Joe. I appreciate the question, and thanks for participating. So, as I think both James and Kristen have said during their prepared remarks, with the changes that we've made, we now can assure that we will fund all of our programs. And as I've mentioned, I think in the past, some of these programs are co-funded and many of them are being operated in areas where we'll get R&D rebates, which contributes to a reduction in costs. And some of them are completely funded by the other partner, but yet we retain rights to our product. With that said, we now can project with a fair degree of confidence that we will be with our existing capital, able to fund all of our programs, both ongoing and proposed, as outlined in the corporate presentation, through to availability of data. And so that's into the early part of 2026. And all of the things that we talked about starting are already included in that, as are all of the drug and manufacturing needs, including clinical supplies, as well as the appropriate

validations and stability manufacturing and lots to keep the CMC portion of development essentially in line with the clinical portion that that's great to hear and then curious with all the programs that you have discussed today you know which one of these indications have the or I'd say like the rate limiting step with regard to patient enrollment with regard to pay competing for patients with other studies well

There are a fair number of pancreatic cancer studies ongoing, and there are studies in all these other solid tumors. So we do have competition. But I think there's quite a bit of enthusiasm about our trial. And, you know what, rather than fumbling through this answer, I'm going to put Kristen on the spot and see if she can, you know, give some sense about what we think will be the toughest to enroll and how we've constructed our enrollment projections.

Yeah, thanks for the question. And I'll start off by saying we do have a lot in pancreatic cancer, but we've been very careful to not have them cannibalize each other such that some, as you well know probably, pancreatic cancer has two main standards of care, filferinoxin, GEM, NAB, paclitaxel. So we've tried to exploit both of those standards of care such that those who are eligible for filferinox will have a separate trial and those who are eligible for GEM, NAB are in a separate trial. And then in one of our pancreatic trials, we are doing non-resectable locally advanced such that we could change a tumor that is non-resectable and make it resectable. So that's a different patient population. For the ASCEND trial, there really isn't competition because it is occurring in Australia. So if I were to answer the second question, which is the hardest to recruit, I would say one of the arms of the bolster trial may be difficult to recruit, which is esophageal I don't know, excuse me, esophageal carcinoma squamous cell type. It's not the most common in the U.S., but it is the most challenging to treat. So we may have to go to Asia and other parts of Europe to recruit this trial. But for the most part, we've been very diligent and strategic in choosing our patient populations such that we wouldn't internally cannibalize each of our trials.

Got it. Appreciate all the color.

You're welcome.

Thank you. Our next question is a follow-up from Pete Enderlin with MozPartners. Your line is open.

Yeah, just a quick one. What do you have in the way of remaining New Jersey tax NOLs, and what would be the timing of their availability and contemplated use of those?

Okay. Well, the contemplated use is easy. We apply that to You know, what generally is characterized as general corporate.

How soon do you take advantage of them? I know you use it for whatever, but.

All right. So we have approximately two to three million dollars left under the current program, which which caps every company at 20 million dollars lifetime benefits. That could change. It's already changed once two years ago from 15 to 20. The state could raise it again. But under the current cap, we have a couple of years of availability left in terms of and we probably collect roughly half next year and half of what's remaining the following year. And that would probably take us to the cap. So that's that's roughly it's somewhere between one to one and a half million dollars a year. over the next two years is what remains in terms of current eligibility.

Okay. Well, every bit helps. Thanks a lot.

Okay. Thank you.

Thank you. This concludes the question and answer session. I would now like to turn the call back over to Dr. Mazzo for closing remarks.

Thanks, Operator. And again, thank you all for participating to today's call, and I really appreciated the questions that gave us the opportunity to provide some additional color. 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 in Masada, and we wish you a very good evening. Thank you and goodbye.

Thank you for your participation. This does include the program. You may now disconnect. Everyone, have a great day.