Caladrius Biosciences Inc

LSE:0HS8

Earnings Call Transcript 2023-Q1

[Operator]

Welcome to the Lisata Therapeutics First Quarter 2023 Financial Results and Business Update Conference Call. Currently all participants are in listen-only mode. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, May 9, 2023.

I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

[John Menditto, VP, IR and Corporate Communications]

Thank you, operator, and good afternoon, everyone. Welcome to Lisata'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 Nisco, 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 & 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 e-mail distribution list, please email me at [e-mail].

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 Lisata. I encourage you to review the company's filings with the Securities and Exchange Commission including, without limitation, its forms 10-Q, 8-K and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, May 9, 2023. Lisata 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.

[David Mazzo, CEO]

There we are. We're having technical difficulties today. My apologies, everyone. And 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, Lisata is a clinical-stage therapeutic development company with a novel solid tumor targeting and penetration technology to improve the efficacy of anticancer drugs. Our development portfolio contains programs that are designed to bring significant therapeutic improvement in the treatment of solid tumors in a pharmacoeconomically attractive paradigm.

LSTA1, 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 anticancer agents of different modalities. Based on substantial preclinical and, most importantly, early human clinical data, we believe that LSTA1 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’ve 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 President -- 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 Lisata. And I will take this opportunity to publicly acknowledge his many contributions to the evolution of Cend Therapeutics and the transaction that formed Lisata.

David was instrumental in leading the efforts to identify a means by which to exploit the promise of LSTA1 in a comprehensive clinical development program as he was in the licensing deal of LSTA1 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 Nisco, our VP of Finance and Treasury, to review and provide commentary on our financial results. James?

[James Nisco, VP, Finance and Treasury]

Thanks, Dave. 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 31, 2023, compared to $3.3 million for the three months ended March 31, 2022, representing a decrease of $0.1 million or 3.2%. This was primarily due to expenses associated with our XOWNA Phase IIb study, the FREEDOM Trial, in the prior year, partially offset by study start-up activities in the current year associated with the planned Phase II proof-of-concept BOLSTER Trial studying LSTA1 in various solid tumors in combination with the corresponding standards of care. Enrollment activities for the LSTA1 Phase IIb ASCEND study and chemistry and manufacturing and control activities for LSTA1.

General and administrative expenses were approximately $3.7 million for the three months ended March 31, 2023, compared to $3.3 million for the three months ended March 31, 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 Cend Therapeutics, an increase in external legal fees and an increase in accounting and tax-related fees.

Overall, net losses were $6.2 million for 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-dilutive 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?

[Kristen Buck]

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 Lisata team.

Lisata'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 health care 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 Lisata's active clinical development programs. Kicking off with our lead product candidate, LSTA or LSTA1, for the treatment of advanced solid tumors in combination with other anticancer 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 anticancer 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, Lisata's approach is to activate the C-end Rule or CendR system, a naturally occurring active transport system to selectively deliver anticancer drugs through the stroma and into the tumor. Lisata's lead product candidate, LSTA1, is an investigational drug that actuates the CendR active transport mechanism while also having the potential to modify the tumor microenvironment and make it less immunosuppressive.

LSTA1 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 operated later on these cells but not necessarily healthy tissue. LSTA1 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 CendR fragment. The CendR 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 C-end Rule active transport pathway and ferry anticancer drugs more efficiently into solid tumors.

Additionally, LSTA1 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 anticancer drugs used against solid tumors.

These results come internally from Lisata 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 non-clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA-based therapeutics.

Clinically, LSTA1 has demonstrated favorable safety, tolerability and activity to enhance the delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LSTA1 to enhance a variety of anticancer treatment modalities in a range of solid tumors. Currently, LSTA1 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 LSTA1 in combination with gemcitabine and nab-paclitaxel 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 Gastro-Intestinal Cancer Trials Group or AGITG. In collaboration with the NHMRC Clinical Trials Centre at The University of Sydney.

We are very pleased with the work of AGITG. To date, an 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 WARPNINE, we treated two of our first patients in the iLSTA Trial in Australia, evaluating LSTA1 in combination with standard of care, gemcitabine and nab-paclitaxel chemotherapy; and immunotherapy that is durvalumab, as a first-line treatment in locally advanced nonresectable pancreatic ductal adenocarcinoma.

This is the first of several planned trials in which we are expanding the study of LSTA1'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 Ib/IIa open-label trial of LSTA1 in combination with neoadjuvant FOLFIRINOX-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.

LSTA1 is also currently being evaluated in combination with gemcitabine and nab-paclitaxel in a Phase Ib/IIa 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 LSTA1 is a Phase II placebo-controlled basket trial evaluating LSTA1 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, iGoLSTA, a Phase Ib/IIa proof-of-concept safety and early efficacy study evaluating LSTA1 in combination with nivolumab and FOLFIRINOX as a first-line treatment in locally advanced nonresectable 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 LSTA1 in combination with temozolomide in glioblastoma multiforme, or GBM, as well as LSTA1 in combination with HIPEC, intraoperative 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 LSTA12, also known as HONEDRA in Japan, our product candidate for the treatment of critical limb ischemia, or CLI, and Buerger’s disease. HONEDRA is the company's SAKIGAKE-designated product candidate for the treatment of CLI and Buerger'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 formed 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 an advice on how to proceed -- excuse me, 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, LSTA201 for the treatment of diabetic kidney disease, or DKD. In 2022, the company initiated a Phase Ib open-label, proof-of-concept trial evaluating LSTA201, a CD34+ 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 LSTA201 to regenerate kidney function.

As we reported on 6 February 2023, the top line results from the study showed that LSTA201 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+ cell therapy for the treatment of diabetic kidney disease.

Further development of LSTA201 though will certainly require significantly larger studies and 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.

[David Mazzo, CEO]

Thanks, Kristen. As Kristen has outlined, the Lisata 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.

[Operator]

[Operator Instructions] Our first question comes from Steve Brozak with WBB Securities. Your line is open.

[Steve Brozak, WBB Securities]

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 in the queue after that. Thank you.

[David Mazzo, CEO]

Thanks, Steve. Nice to talk to you. And appreciate your question. So before we started these trials, Kristen spent a good deal of time talking to key opinion leaders, 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 the 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 pharmacoeconomically 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 LSTA1 is doing exactly what we reported to do.

[Steve Brozak, WBB Securities]

Can I tack on one addendum? On the regulatory side, given the fact that 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 in the queue.

[David Mazzo, CEO]

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 we -- and by adding, I mean we simply co-administer these products. So there's no -- 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 anticancer agents with LSTA1, so lots of preclinical work doesn't need to be done. Separate toxicology doesn't need to be done on these new entities. And the fact that LSTA1 in and of itself seems to be so benign from a safety perspective makes this very easy to go -- 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 EMA in Europe. And so far, we haven't seen any particular hurdles, and the discussions are proceeding as we expected.

[Steve Brozak, WBB Securities]

Go it. Again, thanks for taking the questions. And let me hop back in the queue.

[David Mazzo, CEO]

Thanks, Steve.

[Operator]

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

[Kemp Dolliver, Brookline Capital Markets]

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

[David Mazzo, CEO]

Certainly, Kemp. 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 has had sort of a single purpose was to replicate the Phase Ib/IIa 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 saw 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 and that we added a second cohort of patients, very creatively called cohort B. And that second cohort actually will receive two doses of LSTA1 separated by about four hours. So they still receive gemcitabine, nab-paclitaxel and LSTA1 essentially co-administered at the start. But four hours later, they'll get a second dose of LSTA1.

And the reason for that is, if you look at the pharmacokinetic profile, the Cmax, the Tmax and the half-life of these different compounds, you realize that gemcitabine has a half-life of roughly 2 hours or 90 minutes or something like that. LSTA1 has a half-life of about the same, but nab-paclitaxel has a half-life of about 10 to 12 hours. And so there was at least some thought process that said if you waited two or more half-lives after the first dose of LSTA1, essentially, you're outside the therapeutic range of LSTA1, gemcitabine is all gone, but you're still within the therapeutic range of nab-paclitaxel. And a second dose of LSTA1 might provoke improved penetration of the remaining nab-paclitaxel 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 2 cohorts, and so we can compare each cohort against placebo and then the 2 cohorts against each other and then perhaps the combination of the 2 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 III trial that would follow.

[Kemp Dolliver, Brookline Capital Markets]

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

[David Mazzo, CEO]

Yes, that's our -- 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.

[Kemp Dolliver, Brookline Capital Markets]

Super. Thank you.

[Operator]

Our next question comes from Pete Enderlin with MAZ Partners. Your line is open

[Pete Enderlin, MAZ Partner]

Thank you. Hi, everybody. Conceptually, I thought that, originally, the idea was that LSTA1 could either be co-administered, which is what you're just talking about, or tethered. And you just said, Dave that that's not really what you're anticipating now. So is it true that you're really not contemplating...

[David Mazzo, CEO]

No, let me clarify. Okay. So the two approaches, either co-administration or tethering, remain distinct possibilities. I think 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 tethering, you create a new chemical entity that needs to be fully characterized both biologically and chemically. And those are much -- you're basically starting from 0 with that kind of product.

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.

[Pete Enderlin, MAZ Partner]

Thanks for clarifying that. And then sort of looking several years ahead, 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 or 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 gemcitabine or paclitaxel and LSTA1, and you could either have a package sale or sell them and price them independently. So which way do you typically anticipate going?

[David Mazzo, CEO]

So we would -- right now, the anticipation is that this will be an add-on to existing therapy. And those -- 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 a 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 a large list of nonexclusive 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.

[Pete Enderlin, MAZ Partner]

But -- and the initial agreements that you have with these other players, you don't really spell out exactly what -- any such combination?

[David Mazzo, CEO]

The current agreements are essentially development agreements. They just say that we will work together to demonstrate, hopefully, that the addition of LSTA1 improves the products that are already considered standard of care. And if that works, as I said, that will be enough to improve everyone's bottom line in the long run. But 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.

[Pete Enderlin, MAZ Partner]

Right. Okay, great. Thanks a lot.

[Operator]

Thank you. Our next question comes from Joe Pantginis with H.C. Wainwright. Your line is open.

[Joe Pantginis, H.C. Wainwright]

Hey, everybody, good afternoon. And thanks for taking the question. Two questions, if you don't mind, Dave. So first, 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 LSTA1 as well as your interim to more long-term needs?

[David Mazzo, CEO]

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.

[Joe Pantginis, H.C. Wainwright]

That's great to hear. And then curious, with all the programs that you discussed today, which one of these indications have the -- I would say, like the rate-limiting step with regard to patient enrollment with regard to competing for patients with other studies?

[David Mazzo, CEO]

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 is 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 give some sense about what we think will be the toughest to enroll and how we've constructed our enrollment projections.

[Kristen Buck]

Yes, 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 2 main standards of care, FOLFIRINOX and gem/nab-paclitaxel. So we've tried to exploit both of those standards of care such that those who are eligible for FOLFIRINOX 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 nonresectable locally advanced such that we could change a tumor that is nonresectable 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 -- 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 population such that we wouldn't internally cannibalize each of our trials.

[Joe Pantginis, H.C. Wainwright]

Got it. Appreciate all the color.

[Operator]

Our next question is a follow-up from Pete Enderlin with MAZ Partners. Your line is open.

[Pete Enderlin, MAZ Partner]

Yes, 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?

[David Mazzo, CEO]

Okay. Well, the contemplated use is easy. We applied that to what generally is characterized as general...

[Pete Enderlin, MAZ Partner]

No, no, I mean, how soon you take advantage of them. I know you use it for whatever. But...

[David Mazzo, CEO]

Right. So we have approximately $2 million to $3 million left under the current program, which caps every company at $20 million lifetime benefit. That could change. It's already changed once two years ago from $15 million to $20 million. 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 roughly somewhere between $1 million to $1.5 million a year over the next two years is what remains in terms of current eligibility.

[Pete Enderlin, MAZ Partner]

Okay. Well, every bit helps.

[David Mazzo, CEO]

Yes.

[Pete Enderlin, MAZ Partner]

Nice one.

[Operator]

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.

[David Mazzo, CEO]

Thanks, operator. And again, thank you all for participating to today's call. And I really appreciate 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 continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support in Lisata.

And we wish you a very good evening. Thank you, and goodbye.

[Operator]

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